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 BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia (NCT02933320), a non-randomized phase 1, phase 2 study. The primary outcome is Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02933320 |
| Phase | Phase 1, Phase 2 |
| Condition | B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 14 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cancer Research UK |
| Results posted | Yes |
2. Clinical Question
Population
Patients with CD32b-positive B-cell malignancy, including B-cell lymphoma, chronic lymphocytic leukaemia and Waldenström macroglobulinaemia. The expansion-phase descriptions also specify chronic lymphocytic leukaemia and mantle cell lymphoma cohorts.
Intervention
BI-1206 given as a single agent or in combination with the anti-CD20 antibody rituximab. The trial included dose-escalation and expansion phases for both approaches.
Comparator
There was no randomized control group. The registry describes separate non-randomized treatment arms, so comparisons between them are not like-for-like controlled comparisons.
Primary question
What dose of BI-1206 can be given safely, alone or with rituximab, and what safety events occur during treatment and follow-up?
The trial’s stated purpose was to identify a tolerable dose and further evaluate BI-1206 in both treatment settings. Its primary outcome concerns adverse events, serious adverse events, dose-limiting toxicities and laboratory parameters, including whether events were considered causally related to BI-1206. The stated objective was to recommend a dose for future trials by identifying the highest safe dose that could be given to patients.
This is a dose-finding and safety question, not a randomized test of whether BI-1206 improves outcomes compared with another treatment. Although the registry lists best disease response among secondary outcomes, posted results for that outcome are not reported in the registry record. The record also does not report a direct comparative efficacy estimate for BI-1206 alone versus the combination.
3. Trial Design
This was a phase I/IIa, non-randomized, open-label trial with a parallel-arm model. The registry reports enrollment of 14 and lists the study as completed. The recorded start date is 2016-10-27, and the primary completion date is 2020-03-19. These are registry dates; they do not by themselves describe how long any individual participant was followed.
The study had four named treatment groups. Part A included dose escalation of BI-1206 as a single agent and dose escalation of BI-1206 with rituximab. The single-agent description specifies intravenous BI-1206 once weekly for four weeks, followed by a four-week follow-up period; the eight-week period was classified as induction therapy. The combination escalation description says the study assessed an appropriate BI-1206 dose for use with rituximab.
Part B was described as expansion phases at the recommended phase 2 dose determined in the corresponding Part A arm. Each expansion description allowed for up to 25 patients, with a stated minimum of 12 chronic lymphocytic leukaemia patients and six mantle cell lymphoma patients. These are planned cohort descriptions, not evidence that those enrollment targets were reached. The registry reports zero participants at risk in both Part B safety group entries.
Because treatment allocation was not randomized and masking was absent, participants and investigators knew the treatment being given. There is no randomized control arm to balance prognostic factors across treatments. The registry record does not report further details of allocation procedures, a formal sample-size justification, interim analyses or a statistical analysis plan.
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.
Overall Study
| Stage | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase |
|---|---|---|---|---|
| STARTED | 13 | 1 | 0 | 0 |
| COMPLETED | 13 | 1 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety population
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: Trial terminated before opening Part B.
| Characteristic | Unit | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 13 | 1 | 0 | 0 | 14 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | — | — | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 1 | — | — | 6 |
| Age, Categorical: >=65 years | Participants | 8 | 0 | — | — | 8 |
| Sex: Female, Male: Female | Participants | 5 | 1 | — | — | 6 |
| Sex: Female, Male: Male | Participants | 8 | 0 | — | — | 8 |
| Race and Ethnicity Not Collected | Participants | — | — | — | — | 0 |
| Region of Enrollment: United Kingdom | participants | 13 | 1 | — | — | 14 |
6. Primary Endpoint
The registry lists the primary outcome as Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206., measured over Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of events |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is a safety assessment. It records adverse events, serious adverse events, dose-limiting toxicities graded according to NCI-CTCAE Version 4.02, laboratory parameters and the assessed causal relationship of events to BI-1206. The outcome is expressed as a number of events, and the stated population is the safety population.
This type of endpoint is used in dose-finding research because tolerability and toxic effects are central to deciding which dose should be considered for further study. The trial description says the goal was to identify the highest safe dose and recommend a dose for future trials. A dose-limiting toxicity is a safety event used in that dose-finding context; the registry record does not provide a separate definition of which events qualified as dose limiting or the decision rule used to select a dose.
Safety data were collected from written informed consent through 125 days after the final administration of BI-1206 or rituximab. The registry lists group-level safety counts, but it does not report a dose recommendation or a complete account of the dose-escalation decisions. The endpoint therefore describes the safety focus of the trial, while the posted figures alone do not establish a recommended dose.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results are concentrated in the Part A dose-escalation entries. In the BI-1206 single-agent escalation group, 10 of 13 participants at risk were reported as affected by at least one serious adverse event; 13 of 13 were reported as affected by other adverse events. One death was reported in that group. In the combination escalation group, one of one participants at risk was reported as affected by a serious adverse event and by other adverse events; no deaths were reported in that entry.
The registry reports zero participants at risk and zero affected for both Part B expansion groups. This means that those group entries do not contribute safety observations in the posted results. It should not be interpreted as evidence that the expansion treatments had no adverse events. The registry record does not explain the absence of participants at risk in those entries.
The serious-event terms listed include infusion related reaction at 100.0%, pneumonia at 15.4%, pleural effusion at 15.4%, atrial fibrillation at 7.7%, abdominal pain at 7.7% and diarrhoea at 7.7%. The denominator and exact calculation basis for these term percentages are not reported in the registry record. These percentages should therefore be read as the registry’s listed values, not as rates that can be reconstructed from the group counts. Event terms can also describe different events or participants, so the percentages should not be added to create a total.
These counts are descriptive. With non-randomized groups and a very small number of participants in the combination escalation entry, the figures cannot support a reliable causal comparison between single-agent and combination treatment. Differences in group size and treatment setting further limit direct comparison. The registry does not report confidence intervals, adjusted estimates, formal tests or analyses of disease response. Thus, the safety counts document events in the reported groups but do not quantify comparative risk precisely or establish whether an event was caused by treatment.
The primary endpoint includes the assessment of causality, but the posted group counts do not show event-by-event causality assessments or dose-limiting toxicity counts. The specific dose recommended for future trials is also not reported in the registry record. Interpretation should remain limited to the posted safety counts and the stated design.
9. Statistical Methods Explained
The trial’s design and posted results call for a distinction between descriptive safety reporting and a controlled treatment comparison. The study was non-randomized and unmasked. In a randomized comparison, allocation by chance can help make treatment groups comparable with respect to measured and unmeasured characteristics. Here, the registry does not describe random allocation, and the arms were created for dose escalation and expansion rather than as matched treatment groups. As a result, group differences cannot be interpreted as an unbiased estimate of the effect of adding rituximab or of using BI-1206 alone.
What does a safety count describe?
A count of participants affected by an adverse event answers how many people in a defined group had at least one event of the specified kind, according to the registry’s reporting. A count of events may instead include repeated events in the same participant. The primary outcome is labelled as a number of events, while the adverse-event group results also report participants at risk and participants affected. Those measures are not interchangeable: one participant may experience more than one event. The record does not provide enough detail to reconstruct event-level data or determine how repeated events were handled in every listing.
Serious adverse events are a subset defined by seriousness criteria, while other adverse events form a separate reported category in the group summaries. The entries should be read within their named treatment groups and risk populations. A count of affected participants is not, by itself, a rate per unit of follow-up time. Although the endpoint specifies a safety collection period ending 125 days after the final administration, the group summaries do not provide person-time or event timing. They therefore do not support a time-adjusted comparison.
Why is dose escalation different from efficacy testing?
Dose-escalation research is intended to investigate tolerability across dose levels and inform a dose choice for later research. It is not necessarily designed to estimate treatment benefit with the precision expected from a larger controlled trial. The registry describes the goal of finding the highest safe dose, but the detailed dose levels, dose-limiting toxicity rules and decision process are not reported in the registry record. The posted group counts cannot be used to infer those rules or to identify the dose ultimately selected.
For an efficacy comparison, a statistical analysis would ordinarily define an outcome, a contrast between treatments and a method for quantifying uncertainty. A confidence interval, in general, expresses the range of effect estimates compatible with the observed data under the model and assumptions used. A narrow interval indicates greater precision than a wide interval. No efficacy effect estimate or confidence interval is reported for the listed best disease response outcome, and no formal treatment comparison is reported in the registry record. General descriptions of these methods do not imply that they were used in this trial.
How should planning calculations be understood?
Planning illustrations based on an observed effect are not observed trial outcomes. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation; the target effect is a stated fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm for a specified power. For time-to-event outcomes, the stated convention is a total number of events using the Schoenfeld approach. These are planning conventions, not evidence that the trial was designed with those assumptions or that a particular power was achieved.
In general, planning calculations based on an observed effect are sensitive to how that effect was estimated. If an early or small study produces an unusually large observed effect, a calculation using that estimate can imply a smaller future study than would be needed for a more modest effect. Considering a fraction of the observed effect illustrates sensitivity to the assumed effect size; it does not prove that the fraction is a realistic treatment effect. These calculations should not be called observed power, and they do not change the descriptive status of the safety results. The specific planning outputs and the effect estimate on which they depend are not reported in the registry record.
Why can over-dispersion matter?
In general, count outcomes may vary more across participants or groups than a simple statistical model assumes. This extra variation is called over-dispersion. If it is ignored, uncertainty may be understated and statistical tests may appear more decisive than the data warrant. Sparse safety counts and differing group sizes can make model choice especially important. The registry does not report a count model, an over-dispersion assessment or inferential analyses for these safety figures, so no such model should be attributed to the trial.
The registry lists 12 outcome measures and zero analyses. That describes the posted analysis record, not a finding that no statistical work was done outside the registry. The registry record does not report the statistical methods used for the outcomes, confidence intervals, adjustment procedures or a formal analysis population beyond the safety population named for the primary outcome. Consequently, interpretation should prioritize the displayed descriptive counts and avoid implying that they arose from a specified inferential model.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including safety, pharmacokinetic measures, anti-drug antibody response, peripheral blood B-lymphocyte depletion and best disease response. When a study examines multiple outcomes, the chance of finding an apparently notable result by chance can increase if many statistical tests are performed. In general, multiplicity methods can control or describe that risk. The registry record does not report whether any multiplicity adjustment was planned or used. It also lists zero analyses, so no adjusted or unadjusted outcome tests are reported there.
Missing-data methods are not reported in the registry record. The record does not explain how missing outcome measurements, incomplete follow-up or withdrawals were handled in analyses. It does not report the amount or pattern of missing data for the listed outcomes, so the impact of missingness cannot be assessed from the posted results.
The primary outcome names the safety population, but definitions for other analysis populations are not reported in the registry record. The record does not state whether separate intention-to-treat, per-protocol, pharmacokinetic or response-evaluable populations were defined. The safety group entries give participants at risk and affected for the escalation groups, with zero at risk in both expansion entries, but those counts do not explain population-selection rules or missing observations.
Interim-analysis procedures and the detailed statistical plan are not reported in the registry record. Without those details, it is not possible to determine whether outcome selection, repeated assessment or analysis decisions were prespecified. These omissions limit assessment of the completeness and confirmatory status of the posted findings; they do not establish that particular procedures were or were not conducted outside the registry.
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 |
|---|---|---|---|
| Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 10 | 13 | 76.9% |
| Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 1 of 13 |
| Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 0 of 1 |
| Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 of 0 |
| Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 13 of 13 |
| Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 of 1 |
| Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 of 0 |
| Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | 5 of 13 | 1 of 1 | n/a of 0 | n/a of 0 |
| Pneumonia | Infections and infestations | 2 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 2 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Atrial fibrillation | Cardiac disorders | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Abdominal pain | Gastrointestinal disorders | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Diarrhoea | Gastrointestinal disorders | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Non-cardiac chest pain | General disorders | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Abdominal abscess | Infections and infestations | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Lower respiratory tract infection | Infections and infestations | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Metapneumovirus infection | Infections and infestations | 1 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | 9 of 13 | 1 of 1 | n/a of 0 | n/a of 0 |
| Urticaria | Skin and subcutaneous tissue disorders | 8 of 13 | 1 of 1 | n/a of 0 | n/a of 0 |
| Fatigue | General disorders | 8 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Hypotension | Vascular disorders | 6 of 13 | 1 of 1 | n/a of 0 | n/a of 0 |
| Chills | General disorders | 6 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Tachycardia | Cardiac disorders | 4 of 13 | 1 of 1 | n/a of 0 | n/a of 0 |
| Nausea | Gastrointestinal disorders | 5 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Pyrexia | General disorders | 5 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Flushing | Vascular disorders | 5 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
| Anaemia | Blood and lymphatic system disorders | 4 of 13 | 0 of 1 | n/a of 0 | n/a of 0 |
Serious events with the highest arm-level rate: infusion related reaction (100.0%), pneumonia (15.4%), pleural effusion (15.4%), atrial fibrillation (7.7%), abdominal pain (7.7%).
The serious adverse event figures are reported separately for each treatment-group entry. In Part A’s single-agent escalation group, 10 of 13 participants at risk were affected by a serious adverse event. In Part A’s combination escalation group, one of one participants at risk was affected. The corresponding Part B entries report zero at risk and zero affected. These are participant counts, not event counts, and the risk denominators are small, particularly in the combination escalation entry.
One death is listed for the single-agent escalation group; no deaths are listed for the other groups. The registry does not state in these figures whether the death was considered treatment-related, nor does the count alone establish cause.
The listed serious-event terms have percentages, but their denominators are not reported in the registry record. Do not treat them as directly comparable group-specific rates or add them together. A participant may have more than one event, and the registry listing does not provide the event-level information needed to clarify overlap. The figures are descriptive reports of safety experience, not estimates from a randomized comparison.
12. What the Result Does, and Does Not, Mean
The record establishes that this was a non-randomized phase I/IIa study designed to investigate BI-1206 dose tolerability as a single agent and with rituximab. It reports serious and other adverse-event counts for the Part A escalation groups, alongside deaths and a list of serious-event terms. These results describe the safety observations recorded for those entries; they do not establish a comparative treatment effect.
The combination escalation entry has one participant at risk, while the single-agent escalation entry has 13. Such sparse data provide limited precision, and the unequal group sizes make informal comparisons especially difficult. The study’s non-randomized design also means that differences between groups could reflect differences in participants, treatment setting or other factors, rather than treatment alone. The registry does not report adjusted estimates or uncertainty intervals that would quantify these limitations.
The record does not report a dose recommendation, detailed dose-limiting toxicity results, or posted results for best disease response. It therefore does not establish from these registry results whether BI-1206, alone or with rituximab, changes disease outcomes. The listed secondary outcomes indicate what was assessed, but listing an outcome is not the same as reporting its results.
Nor do zero at-risk entries in the expansion groups show that those treatments had no adverse events. They indicate that no safety population is reported for those group entries. More broadly, absence of a posted result should not be interpreted as a finding of no effect or no harm. The appropriate reading is bounded by the available registry counts and the record’s stated design and outcome definitions.
13. Why This Trial Matters Statistically
This study illustrates why the statistical question must match the design. A dose-escalation study primarily addresses tolerability and dose selection. Its safety counts can help describe observed events, but they do not function as a randomized test of treatment benefit. Keeping those aims separate prevents a safety-focused record from being read as if it established comparative efficacy.
The trial also shows why denominators matter. A count affected is most interpretable alongside the number at risk in the same group and with awareness that repeated events may occur in one person. In the combination escalation entry, the reported risk population is one participant, so the count is particularly sensitive to the experience of that individual. A percentage without a clearly reported denominator is harder to interpret and should not be reverse-engineered from other group summaries.
Finally, the record makes the distinction between planned cohorts and observed results important. Expansion descriptions include intended cohort sizes and disease composition, but the posted safety entries show zero at risk for those groups. Planned enrollment descriptions should not be mistaken for achieved enrollment or analyzed data. Likewise, planning illustrations based on an observed effect are not observed power and do not replace a trial-specific design justification.
These points are relevant when reading early-phase clinical research more generally: identify the objective, distinguish participant counts from event counts, examine the analysis population, and avoid causal comparisons unsupported by allocation and analysis. In this record, those distinctions keep interpretation aligned with what the registry actually reports.
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 main limitation is the small and unevenly populated safety groups reported in the registry. The single-agent escalation group lists 13 participants at risk, while the combination escalation group lists one. The expansion entries list zero at risk. These figures leave little basis for precise estimates, and the registry does not provide confidence intervals or other measures of uncertainty.
The trial was non-randomized and unmasked, with no like-for-like control group. Comparisons across arms may be affected by differences in participants or study context. The registry does not report adjusted comparisons, detailed dose levels, the dose-limiting toxicity decision rule or the final dose recommendation. Those omissions limit evaluation of how the dose-finding objective was implemented and resolved.
There are also reporting limitations. The registry lists secondary outcome domains but does not report their results in the posted record. It does not describe missing-data handling, multiplicity procedures, analysis populations beyond the safety population, or the statistical methods for the outcomes. The denominator for the listed serious-event term percentages is not reported. Event-level details, timing and causal assessments are not included in the group counts.
Finally, the planned expansion cohort descriptions should not be read as evidence that those cohorts were completed at the stated targets. The discrepancy between planned cohort descriptions and zero participants at risk in the expansion safety entries is not explained in the registry record. These limitations constrain both statistical interpretation and assessment of completeness.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia — NCT02933320.
- Registry record last updated 2021-07-08; status last verified 2021-06.
- Results first posted 2021-07-08.
- 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
NCT02933320 is a completed, non-randomized, open-label phase I/IIa trial sponsored by Cancer Research UK. It investigated BI-1206 as a single agent and in combination with rituximab in CD32b-positive B-cell malignancies. The registry reports enrollment of 14 and a parallel-arm design with dose-escalation and expansion phases.
The primary outcome concerned adverse events, serious adverse events, dose-limiting toxicities and laboratory parameters, with safety data collected through 125 days after final administration. Posted safety counts are reported for the Part A escalation groups; both Part B expansion entries report zero at risk. The registry lists 12 outcome measures and zero analyses. It does not report a dose recommendation, formal comparative analysis, or results for the listed best disease response outcome.