This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies (NCT03829501), a non-randomized phase 1, phase 2 study. The primary outcome is Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03829501 |
| Phase | Phase 1, Phase 2 |
| Condition | Squamous Cell Carcinoma of Head and Neck, Non-small Cell Lung Cancer, Hepatocellular Carcinoma |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 222 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kymab Limited |
| Results posted | Yes |
2. Clinical Question
Population
Adults with selected advanced malignancies, including pancreatic cancer, triple negative breast cancer and head and neck squamous cell carcinoma in the Phase 2 cohorts. The study description focused on people for whom no known beneficial options were available, or who had exhausted such options.
Intervention
Alomfilimab was studied as a single agent and in combination with atezolizumab. The registry describes intravenous infusion every 3 weeks, with alomfilimab doses varying by phase and cohort.
Comparator
There was no randomized control group. The study was non-randomized and used sequential groups, so its dose and disease cohorts are not like-for-like control comparisons.
Primary question
The primary endpoint asked how many Phase 1 participants experienced treatment-emergent adverse events. The broader study also assessed safety, tolerability and efficacy, but outcome analyses are not reported in the registry record.
The study examined alomfilimab across a range of doses, first as a single agent and also in combination with atezolizumab. Its Phase 2 combination cohorts included participants with pancreatic cancer, triple negative breast cancer or head and neck squamous cell carcinoma. Those cohorts were further described by prior anti-PD-(L)1 treatment status. The registry identifies additional malignancies among the study conditions, but the described Phase 2 cohorts focus on those three cancer types.
The primary endpoint was a safety count rather than a direct comparison of tumor response or survival. Secondary outcomes listed response, progression-free survival, duration of response, overall survival rates and treatment-emergent adverse events. The record therefore poses a broad safety and efficacy question, but the posted numerical results represented in these summaries concern adverse events. Efficacy outcome analyses are not reported in the registry record.
Because participants were not randomly allocated to comparable treatment groups, differences in the observed counts across dose or disease cohorts cannot be read as treatment effects. Cohorts may differ in disease, prior treatment and other characteristics. The registry record does not report an efficacy comparison that would resolve those differences.
3. Trial Design
This was a Phase 1/2, open-label, multicenter study with non-randomized allocation and a sequential model. The registry record lists an enrollment of 222 and a status of terminated. The start date was 2019-01-28, and the primary completion date was 2024-10-03. The reason for termination is not reported in the registry record.
In Phase 1, participants received alomfilimab alone at doses from 0.8 to 240 mg, or alomfilimab from 2.4 to 80 mg with atezolizumab 1200 mg. In Phase 2, combination cohorts received alomfilimab from 2.4 to 24 mg with atezolizumab 1200 mg. The Phase 2 descriptions distinguish participants who were anti-PD-(L)1 naïve from those who were pre-treated, and identify pancreatic cancer, triple negative breast cancer and head and neck squamous cell carcinoma cohorts. Infusions were scheduled every 3 weeks.
Open-label means the study was not masked. Non-randomized allocation means assignment was not by chance among comparable treatment groups, and sequential means cohorts were studied in an ordered design. The registry record does not report further details of the sequence or the rules used to choose doses and cohorts. These design features suit a study spanning multiple doses and cancer cohorts, but they limit direct comparisons between the observed groups. They should not be treated as randomized arms with a shared control.
The registry lists 21 outcome measures and zero analyses. Consequently, the record identifies planned or registered outcomes but does not provide statistical analysis results for them. The Phase 1 primary safety endpoint is described for participants who received at least one dose of study drug within the relevant phase, grouped by the study drug received at Cycle 1 Day 1.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Only the first 6 of 23 groups are shown.
Overall Study
| Stage | Alomfilimab 0.8 mg | Alomfilimab 2.4 mg | Alomfilimab 8 mg | Alomfilimab 24 mg | Alomfilimab 80 mg | Alomfilimab 240 mg |
|---|---|---|---|---|---|---|
| STARTED | 4 | 5 | 9 | 8 | 7 | 5 |
| Treated | 4 | 5 | 9 | 8 | 7 | 5 |
| Safety Analysis Set | 4 | 5 | 10 | 8 | 7 | 5 |
| COMPLETED | 0 | 1 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 4 | 4 | 9 | 8 | 7 | 5 |
Reasons for not completing this period:
| Reason | Alomfilimab 0.8 mg | Alomfilimab 2.4 mg | Alomfilimab 8 mg | Alomfilimab 24 mg | Alomfilimab 80 mg | Alomfilimab 240 mg |
|---|---|---|---|---|---|---|
| Withdrawal of Consent | 2 | 0 | 3 | 0 | 1 | 1 |
| PD | 0 | 0 | 0 | 2 | 0 | 0 |
| Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 |
| Lost to Follow Up | 0 | 0 | 0 | 0 | 1 | 0 |
| Death | 2 | 4 | 5 | 6 | 5 | 4 |
| Miscellaneous | 0 | 0 | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
Only the first 6 of 24 groups are shown.
| Characteristic | Unit | Alomfilimab 0.8 mg | Alomfilimab 2.4 mg | Alomfilimab 8 mg | Alomfilimab 24 mg | Alomfilimab 80 mg | Alomfilimab 240 mg |
|---|---|---|---|---|---|---|---|
| Participants analysed | 4 | 5 | 9 | 8 | 7 | 5 | |
| Age, Customized: >= 18 - 64 years | Participants | 2 | 2 | 6 | 2 | 4 | 3 |
| Age, Customized: >= 65 to 84 years | Participants | 2 | 3 | 3 | 6 | 3 | 1 |
| Age, Customized: >= 85 years | Participants | 0 | 0 | 0 | 0 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 3 | 3 | 2 | 6 | 3 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 7 | 2 | 4 | 2 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian | Participants | 0 | 0 | 1 | 0 | 1 | 0 |
| Race/Ethnicity, Customized: Black or African American | Participants | 0 | 0 | 0 | 0 | 1 | 0 |
| Race/Ethnicity, Customized: Native Hawaiian or other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 4 | 5 | 8 | 8 | 5 | 5 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Missing | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity Not Collected | Participants | — | — | — | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), measured over From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counted Phase 1 participants who experienced at least one treatment-emergent adverse event (TEAE). A TEAE was defined as an adverse event observed after starting the specific treatment. An adverse event was an untoward medical occurrence after administration of a pharmaceutical product; the event did not have to be caused by that treatment. Clinically significant laboratory, vital-sign and electrocardiogram changes were also reported as adverse events.
The endpoint included serious adverse events, defined in the record by outcomes such as death, life-threatening events, inpatient hospitalization or its prolongation, persistent or significant disability, congenital anomaly or birth defect, or another important medical event. This definition describes seriousness, not proof that the study drug caused the event. The endpoint timeframe ran from the first dose on Day 1 through 30 days after the last dose; maximum treatment exposure was up to approximately 212 weeks.
Counting participants with events is useful in early-phase safety monitoring because it describes how many people experienced an event during exposure. It does not by itself measure event severity, duration, recurrence, or causal relationship to treatment. Nor does it adjust for differing exposure time between participants. The registry record gives the safety population definition but does not report a separate overall numerical result for the primary endpoint in the outcome-analysis listings.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record reports adverse-event counts across dose and disease cohorts, not a randomized comparison. For example, the group receiving alomfilimab 2.4 mg with atezolizumab had 17 participants with serious adverse events among 43 at risk, while the alomfilimab 8 mg with atezolizumab group had 11 among 35. Those counts describe the posted groups. They do not show that one dose caused more or fewer events than another, because allocation was non-randomized and the groups may not be comparable.
Across the listed groups, the number at risk varies substantially. Several disease-specific cohorts contain only a small number of participants. In small groups, each participant contributes appreciably to the observed count, and estimates of event frequency can be imprecise. The registry record does not provide confidence intervals for these adverse-event summaries. Such intervals would express uncertainty around an estimated event frequency; without them, the raw counts should not be mistaken for precise estimates of underlying risk.
The posted summaries distinguish serious adverse events from other adverse events. The counts for other adverse events are high in many groups, but the registry record does not define these as necessarily caused by treatment, and an adverse event need not have a causal relationship to the study drug. Seriousness is a separate classification based on the event's consequences or medical importance. The listed deaths are counts, but the registry record does not establish that these deaths were treatment-related.
Serious-event terms are also listed with percentages, including embolism at 50.0%, seizure and pleural effusion at 33.3% each, dysphagia and cellulitis at 25.0% each, and pneumonia at 22.2%. The denominator and calculation basis for these percentages are not reported in the registry record. They should therefore be read as registry-listed term summaries rather than as population-level event risks.
The study lists efficacy outcomes such as response and progression-free survival, but zero analyses are listed. No efficacy estimates or inferential results are reported in the registry record. The adverse-event summaries consequently cannot answer whether treatment altered tumor response or survival. They also do not support a treatment ranking across dose levels or cancer types.
A planning illustration based on an observed effect is not an observed-power calculation and is not evidence that a trial had adequate power. The registry describes planning assumptions, including a two-sided significance level of 0.05, equal allocation and a normal approximation, but does not report a trial sample-size justification. Since no efficacy analysis is listed, those planning concepts should not be used to infer an unreported clinical result.
9. Statistical Methods Explained
The statistical record is sparse. It identifies a binary primary endpoint: participants with an event, counted rather than modeled as a continuous measurement. The primary outcome description sets out who belongs to the safety analysis set and defines treatment-emergent events. However, the registry record lists zero analyses. It does not report an inferential model, an adjusted comparison, a confidence interval, or a p-value for this endpoint.
What does a participant count tell the reader?
A count tells how many participants in a defined group experienced an event. When the number at risk is also given, the two figures provide context for the size of that group. A count is not the same as a time-to-event measure: it does not indicate when an event occurred or how long participants were observed. Although the endpoint timeframe and maximum exposure are described, group-level exposure time is not reported in the registry record.
In general, event-frequency estimates from small cohorts are uncertain. A confidence interval can show a range of values compatible with the observed data under a specified method. The registry record does not report confidence intervals for these safety counts. That absence matters because raw counts alone can look more conclusive than the data warrant, particularly when cohort sizes vary.
Why does the design affect interpretation?
Randomization is a method for making treatment groups comparable, on average, with respect to measured and unmeasured factors. This study was non-randomized, so its cohorts cannot be assumed exchangeable. The groups also differ by dose, disease and treatment history. A numerical contrast between them may reflect those differences, rather than a dose or treatment effect. The record's explicit warning that the arms are not a like-for-like control comparison is central to interpretation.
Open-label means treatment masking was absent. The registry record does not describe blinded event assessment. In general, knowledge of treatment can influence the reporting or classification of some outcomes, although the extent cannot be determined from these records. That possibility does not establish bias in any particular count; it is a design consideration when interpreting unmasked safety data.
What do the sample-size illustrations mean?
The registry's planning description says illustrations are based on the observed effect, with a two-sided significance level of 0.05, equal allocation and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a report of the original trial design. The registry record does not report the trial's own sample-size justification, and the analysis results needed to evaluate an observed effect are not listed.
In general, a planning sample size describes how many participants per arm would be needed under specified assumptions to reach a chosen probability of detecting an effect of a specified size. It is not the number of participants actually observed, nor does it show that the completed study had a particular probability of success. An observed-power claim would not substitute for an estimate and its uncertainty. The planning illustrations are explicitly not observed power; their numerical results are not reported in the registry record.
What is not specified?
The registry record does not report the statistical analysis plan, handling of missing outcome data, interim analyses, multiplicity adjustment, or a detailed method for analyzing the registered efficacy outcomes. It also does not report the specific analysis used to produce the adverse-event percentages. Those omissions prevent a reader from reconstructing the intended inferential framework or checking whether particular analysis choices were prespecified. General statistical principles can explain why these details matter, but they cannot fill in the missing protocol information.
For safety, the record defines the analysis population as participants who took at least one dose within the relevant phase, grouped by study drug received at Cycle 1 Day 1. This is a treatment-exposed population. It differs conceptually from an intention-to-treat population, which in randomized trials usually retains participants in their assigned groups whether or not they take treatment. Since this study was non-randomized, and no efficacy analysis populations are reported, the registry does not support further assumptions about analysis sets.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 21 outcome measures, including response, progression-free survival, duration of response, overall survival rates and adverse events. It lists zero analyses. A list of outcomes alone does not establish which outcomes were analyzed, how they were prioritized, or whether any statistical findings were obtained.
Multiplicity arises when many outcomes, groups or comparisons are examined. In general, making several statistical tests can increase the chance of at least one apparently notable finding by chance. A prespecified hierarchy or adjustment can address that issue, but the statistical plan and any multiplicity procedure are not reported in the registry record. No adjustment should be assumed.
Missing-data methods are also not reported in the registry record. The primary safety population includes participants who received at least one dose, but this definition does not explain how missing outcome information, incomplete follow-up or withdrawals were handled. The stated endpoint timeframe does not show whether every participant had complete observation across that interval.
The registry does not report interim analyses, analysis methods for the efficacy outcomes, or a sample-size justification. Nor does it give analysis populations for those outcomes. These gaps mean that the registered outcomes cannot be treated as completed statistical findings, and absence of an analysis listing should not be interpreted as a null result.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Alomfilimab 0.8 mg | 1 | 4 | 25.0% |
| Alomfilimab 2.4 mg | 1 | 5 | 20.0% |
| Alomfilimab 8 mg | 3 | 10 | 30.0% |
| Alomfilimab 24 mg | 2 | 8 | 25.0% |
| Alomfilimab 80 mg | 3 | 7 | 42.9% |
| Alomfilimab 240 mg | 2 | 5 | 40.0% |
| Alomfilimab 0.8 mg + Atezolizumab | 2 | 5 | 40.0% |
| Alomfilimab 2.4 mg + Atezolizumab | 17 | 43 | 39.5% |
| Alomfilimab 8 mg + Atezolizumab | 11 | 35 | 31.4% |
| Alomfilimab 24 mg + Atezolizumab | 4 | 9 | 44.4% |
| Alomfilimab 80 mg + Atezolizumab | 3 | 9 | 33.3% |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | 6 | 15 | 40.0% |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer | 2 | 14 | 14.3% |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | 1 | 7 | 14.3% |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC | 2 | 14 | 14.3% |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | 1 | 5 | 20.0% |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC | 1 | 5 | 20.0% |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | 1 | 2 | 50.0% |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer | 0 | 1 | 0.0% |
| Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | 0 | 1 | 0.0% |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC | 2 | 6 | 33.3% |
| Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | 1 | 3 | 33.3% |
| Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC | 4 | 8 | 50.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Alomfilimab 0.8 mg | 2 of 4 |
| Alomfilimab 2.4 mg | 4 of 5 |
| Alomfilimab 8 mg | 5 of 9 |
| Alomfilimab 24 mg | 7 of 8 |
| Alomfilimab 80 mg | 5 of 7 |
| Alomfilimab 240 mg | 4 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Alomfilimab 0.8 mg | 4 of 4 |
| Alomfilimab 2.4 mg | 4 of 5 |
| Alomfilimab 8 mg | 7 of 10 |
| Alomfilimab 24 mg | 7 of 8 |
| Alomfilimab 80 mg | 7 of 7 |
| Alomfilimab 240 mg | 5 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Alomfilimab 0.8 mg | Alomfilimab 2.4 mg | Alomfilimab 8 mg | Alomfilimab 24 mg | Alomfilimab 80 mg | Alomfilimab 240 mg |
|---|---|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 0 of 4 | 1 of 5 | 2 of 10 | 0 of 8 | 1 of 7 | 1 of 5 |
| Pyrexia | General disorders | 0 of 4 | 0 of 5 | 1 of 10 | 1 of 8 | 0 of 7 | 0 of 5 |
| Dysphagia | Gastrointestinal disorders | 0 of 4 | 0 of 5 | 0 of 10 | 0 of 8 | 1 of 7 | 0 of 5 |
| Nausea | Gastrointestinal disorders | 0 of 4 | 0 of 5 | 0 of 10 | 0 of 8 | 1 of 7 | 0 of 5 |
| Vomiting | Gastrointestinal disorders | 0 of 4 | 0 of 5 | 0 of 10 | 0 of 8 | 1 of 7 | 0 of 5 |
| Chills | General disorders | 0 of 4 | 0 of 5 | 1 of 10 | 0 of 8 | 0 of 7 | 0 of 5 |
| Pain | General disorders | 0 of 4 | 0 of 5 | 0 of 10 | 0 of 8 | 1 of 7 | 0 of 5 |
| Atypical pneumonia | Infections and infestations | 0 of 4 | 0 of 5 | 0 of 10 | 0 of 8 | 1 of 7 | 0 of 5 |
| Cellulitis | Infections and infestations | 1 of 4 | 0 of 5 | 0 of 10 | 0 of 8 | 0 of 7 | 0 of 5 |
| Infusion related reaction | Injury, poisoning and procedural complications | 0 of 4 | 0 of 5 | 1 of 10 | 0 of 8 | 0 of 7 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Alomfilimab 0.8 mg | Alomfilimab 2.4 mg | Alomfilimab 8 mg | Alomfilimab 24 mg | Alomfilimab 80 mg | Alomfilimab 240 mg |
|---|---|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 1 of 4 | 1 of 5 | 2 of 10 | 3 of 8 | 1 of 7 | 2 of 5 |
| Fatigue | General disorders | 0 of 4 | 1 of 5 | 1 of 10 | 2 of 8 | 0 of 7 | 3 of 5 |
| Diarrhoea | Gastrointestinal disorders | 0 of 4 | 0 of 5 | 0 of 10 | 3 of 8 | 2 of 7 | 1 of 5 |
| Nausea | Gastrointestinal disorders | 1 of 4 | 0 of 5 | 0 of 10 | 3 of 8 | 2 of 7 | 0 of 5 |
| Infusion related reaction | Injury, poisoning and procedural complications | 1 of 4 | 0 of 5 | 1 of 10 | 1 of 8 | 0 of 7 | 3 of 5 |
| Decreased appetite | Metabolism and nutrition disorders | 1 of 4 | 0 of 5 | 0 of 10 | 2 of 8 | 0 of 7 | 2 of 5 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 4 | 0 of 5 | 2 of 10 | 0 of 8 | 1 of 7 | 1 of 5 |
| Abdominal pain | Gastrointestinal disorders | 0 of 4 | 1 of 5 | 1 of 10 | 2 of 8 | 0 of 7 | 0 of 5 |
| Constipation | Gastrointestinal disorders | 1 of 4 | 0 of 5 | 0 of 10 | 1 of 8 | 1 of 7 | 1 of 5 |
| Asthenia | General disorders | 1 of 4 | 0 of 5 | 0 of 10 | 1 of 8 | 2 of 7 | 0 of 5 |
Serious events with the highest arm-level rate: embolism (50.0%), seizure (33.3%), pleural effusion (33.3%), dysphagia (25.0%), cellulitis (25.0%).
The safety summaries report, for each treatment group, the number at risk and the number affected by serious and other adverse events, as well as deaths. These are counts within the listed cohorts. For example, the alomfilimab 2.4 mg plus atezolizumab group had 17 participants with serious adverse events among 43 at risk; the alomfilimab 8 mg plus atezolizumab group had 11 among 35. The figures should not be interpreted as a randomized comparison or as evidence that dose explains any difference.
Serious adverse events are defined by consequences or medical importance, including death, life-threatening events, hospitalization, significant disability, congenital anomaly or another important medical event. The category does not itself establish causation. The record defines an adverse event as a medical occurrence that need not be causally related to treatment, and the death counts are not identified as treatment-related.
The listed serious-event terms include embolism (50.0%), seizure (33.3%), pleural effusion (33.3%), dysphagia (25.0%), cellulitis (25.0%) and pneumonia (22.2%). Their denominator and calculation basis are not reported in the registry record. These percentages should not be read as the risk of those events in all participants. Cohort sizes differ, and group-level exposure duration is not reported.
12. What the Result Does, and Does Not, Mean
The posted results establish that serious and other adverse events, and deaths, were recorded among participants in the listed treatment cohorts. They give cohort-specific counts and identify selected serious-event terms. Those data are descriptive: they summarize what was reported in groups that received study treatment.
They do not establish that alomfilimab or atezolizumab caused a particular event, because the adverse-event definition does not require causation and the summaries do not provide causal attribution. A count of deaths likewise does not establish treatment-related mortality. The registry record does not report event-level narratives or a comparative analysis that would support stronger conclusions.
The data also do not establish that one dose, combination or disease cohort was safer or less safe than another. The study was non-randomized, the cohorts were sequential, and some were defined by cancer type and prior treatment. These groups are not like-for-like controls. Differences may reflect cohort composition, observation time or chance as well as treatment; the record does not allow those possibilities to be separated.
Although efficacy outcomes are listed, the record contains no analyses. It therefore does not establish response rates, progression-free survival, duration of response or overall survival findings. Lack of reported analyses should not be interpreted as evidence of benefit, lack of benefit or absence of an effect.
In general, a confidence interval communicates the precision of an estimated effect or event frequency, while a comparative model can address differences between groups under stated assumptions. Such inferential results are not reported for the outcomes in this record. The counts remain useful as a description of the reported safety experience, but the limitations of design, cohort size and absent analysis details constrain conclusions.
13. Why This Trial Matters Statistically
This study illustrates a common statistical challenge in early-phase, multi-cohort research: safety information is collected across different doses, combinations, cancers and treatment histories, while the resulting groups may be small and non-comparable. A long list of cohorts can create many possible contrasts, but those contrasts do not become causal comparisons merely because their counts appear side by side.
The distinction between an adverse event and a treatment-caused event is especially important. The registry defines adverse events broadly, and its serious-event classification describes clinical consequences rather than causality. Readers need both ideas to avoid interpreting the safety counts as confirmed drug effects.
The registry also shows why outcome registration and outcome analysis are different. It lists 21 outcome measures but zero analyses. Registered endpoints indicate what the study intended to assess; without reported estimates and analysis methods, they do not answer the efficacy questions. This is particularly consequential in a study whose stated aims include safety and efficacy.
Finally, the record describes planning illustrations separately from the study's own design justification. Such illustrations depend on assumptions about effect size, allocation and statistical methods. They cannot retrospectively establish that an observed result was precise or that a study had adequate power. Careful interpretation keeps the descriptive safety record, the non-randomized design and the absent efficacy analyses distinct.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The record describes a broad set of advanced malignancies and multiple treatment cohorts, but the reported safety groups are not a single homogeneous population. They vary by alomfilimab dose, use of atezolizumab, cancer type and anti-PD-(L)1 treatment history. The cohort-specific counts should therefore remain tied to their group descriptions rather than being read as an overall estimate for every participant or malignancy.
Several listed cohorts are small, so their event counts offer limited precision. No confidence intervals are reported for these counts, and the registry does not report group-level treatment exposure or follow-up time. The maximum treatment exposure is described as up to approximately 212 weeks, but that does not indicate the duration experienced by each group.
The non-randomized, sequential, open-label design limits comparative inference. The record does not report the sequence rules, detailed dose-selection methods, blinded event adjudication, or an analysis plan. It is therefore not possible to assess how those procedures shaped cohort membership or outcome classification.
The study is listed as terminated, but the reason for termination is not reported in the registry record. The registry lists 21 outcomes and zero analyses, leaving efficacy findings and inferential safety analyses unavailable in this record. Missing-data handling, multiplicity procedures, interim analyses and the trial's sample-size justification are also not reported. These limits apply to interpretation of the registry record and do not establish that analyses or information are absent from other sources.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies — NCT03829501.
- Registry record last updated 2025-04-02; status last verified 2025-03.
- Results first posted 2025-04-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03829501 is a Phase 1/2, open-label, multicenter, non-randomized, sequential study of alomfilimab as a single agent and with atezolizumab in adults with selected advanced malignancies. The registry lists enrollment of 222, status as terminated, a start date of 2019-01-28 and a primary completion date of 2024-10-03.
The Phase 1 primary endpoint counted participants with treatment-emergent adverse events. Posted safety summaries give cohort-level counts for serious and other adverse events and deaths. The record lists 21 outcome measures and zero analyses; efficacy results and detailed statistical methods are not reported in the registry record. Because allocation was non-randomized and cohorts differ, the safety counts are descriptive rather than like-for-like treatment comparisons.