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 HCW9218 in Select Advanced Solid Tumors (NCT05322408), a na phase 1 study. The primary outcome is The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05322408 |
| Phase | Phase 1 |
| Condition | Solid Tumor |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
| Results posted | Yes |
2. Clinical Question
Population
Adults with advanced or metastatic solid tumors, excluding pancreatic and primary brain cancers, after failing at least two prior therapies. The registry record identifies solid tumor as the condition and describes enrollment in a single-center phase I study. It does not report further eligibility details in the record.
Intervention
HCW9218, given as monotherapy by subcutaneous injection once every 3 weeks at an assigned dose. The study describes five dose levels: -1 at 0.1 mg/kg, 1 at 0.25 mg/kg, 2 at 0.5 mg/kg, 3 at 0.8 mg/kg, and 4 at 1.2 mg/kg. The record describes HCW9218 as a bifunctional protein complex involving IL-15 signaling and TGF-β trapping.
Comparator
There was no separate comparator arm. The study is listed as single-group, with allocation not applicable and no masking. Comparisons between dose levels, if made in clinical interpretation, are not randomized comparisons and should not be treated as like-for-like control comparisons.
Primary question
The dose-finding component aimed to determine the maximum tolerated dose of HCW9218. The registry describes use of an adaptation of the continual reassessment method, beginning with cohorts of one patient, because little to no toxicity was expected. The record does not report the selected maximum tolerated dose or the analysis leading to it. It also lists response, progression-free survival, and overall survival as secondary outcome topics, without reporting results for those outcomes.
3. Trial Design
This was a completed phase I, single-center, dose-finding study of HCW9218 in select advanced solid tumors. The registry reports enrollment of 18 and describes HCW9218 as monotherapy administered by subcutaneous injection once every 3 weeks. The planned dose levels were -1 at 0.1 mg/kg, 1 at 0.25 mg/kg, 2 at 0.5 mg/kg, 3 at 0.8 mg/kg, and 4 at 1.2 mg/kg. The listed arm is “Administer HCW9218”; there is no separate control arm.
The study is recorded as single-group, with allocation not applicable and masking none. That design is consistent with the stated dose-finding objective: the registry describes use of an adaptation of the continual reassessment method, starting with cohorts of one patient. It does not report the target toxicity probability, detailed dose-escalation rules, or other operating details of that method. Those protocol details should not be inferred from the dose levels alone.
The registry lists a study start of 2022-04-01, primary completion of 2025-01-02, and status completed. Its primary outcome timeframe is through study completion, described as an average of 12 months. The record does not report participant follow-up distributions or whether every participant was followed for the same length of time. The secondary outcome listings include response categories, progression-free survival, and overall survival. Although those topics are named, outcome estimates and their analysis details are not reported in the registry record.
Because dose assignment is not a randomized comparison between treatment groups, differences among dose-level safety counts cannot establish that dose alone caused differences. Participant numbers at each listed dose level are also limited, so the counts are descriptive rather than precise comparative estimates.
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 | HCW9218 Dose Level -1 | HCW9218 Dose Level 1 | HCW9218 Dose Level 2 | HCW9218 Dose Level 3 | HCW9218 Dose Level 4 |
|---|---|---|---|---|---|
| STARTED | 0 | 3 | 3 | 3 | 9 |
| COMPLETED | 0 | 3 | 3 | 3 | 9 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
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.
| Characteristic | Unit | HCW9218 Dose Level 1 | HCW9218 Dose Level 2 | HCW9218 Dose Level 3 | HCW9218 Dose Level 4 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 3 | 9 | 18 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 3 | 6 | 14 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 0 | 3 | 4 |
| Sex: Female, Male: Female | Participants | 1 | 1 | 1 | 6 | 9 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 2 | 3 | 9 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 3 | 3 | 9 | 18 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 2 | 3 | 3 | 7 | 15 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment: United States | participants | 3 | 3 | 3 | 9 | 18 |
6. Primary Endpoint
The registry lists the primary outcome as The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218, measured over through study completion, an average of 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/kg |
| Endpoint classification | not reduced to a single comparison |
The primary objective was to determine the maximum tolerated dose of HCW9218, measured in mg/kg. In an early-phase dose-finding study, this endpoint helps characterize dose-related tolerability and guides selection of a dose for further study. The registry states that the dose-finding component used an adaptation of the continual reassessment method because little to no toxicity was expected, starting with cohorts of one patient.
In general, a dose-finding method uses observed toxicity information alongside a prespecified dose-toxicity model or decision rule to guide dose assignment. The continual reassessment method is a model-based approach; its precise behavior depends on protocol choices, such as the target toxicity level and model specification. Those details are not reported in the registry record, so the exact decision rule cannot be reconstructed from the posted description.
The primary outcome timeframe is through study completion, described as an average of 12 months. The registry record does not report a numeric maximum tolerated dose, a dose-limiting toxicity definition, or the evidence used to select a dose. It therefore identifies the endpoint and general method but does not permit assessment of the study’s primary result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical aim was dose finding, not a randomized test of HCW9218 against another treatment. The registry describes a single-group phase I study with enrollment of 18 and lists five dose levels. Its primary objective was to determine the maximum tolerated dose using an adaptation of the continual reassessment method. However, no numeric maximum tolerated dose or primary analysis is reported in the registry record. The posted information therefore describes the question and design but does not establish the answer to the primary question.
The registry also lists response, progression-free survival, and overall survival as secondary outcome topics. Those are clinically relevant outcome domains, but outcome values, time-to-event estimates, and analysis results are not reported in the registry record. No efficacy conclusion can be drawn from the outcome labels alone. The listed secondary outcomes appear more than once in the outcome description; the record does not explain whether the repeated entries refer to distinct timepoints, populations, or analyses.
The safety information is descriptive by dose level. For serious adverse events, the listed counts are 2 of 3 at dose level 1, 0 of 3 at dose level 2, 0 of 3 at dose level 3, and 4 of 9 at dose level 4. For other adverse events, the counts are 3 of 3, 3 of 3, 3 of 3, and 9 of 9, respectively. Death counts are listed as 3, 3, 2, and 6 across dose levels 1 through 4. These figures do not, by themselves, show when events occurred, whether they were considered related to HCW9218, or whether the dose groups differed in baseline risk or follow-up. The record does not provide enough detail to assign causality.
The single-group structure and small counts at each dose level make dose-level contrasts especially uncertain. The dose groups are not randomized control groups, and their counts should not be interpreted as estimates from a controlled comparison. The registry record reports no statistical analyses. It also does not report confidence intervals or other measures of uncertainty for the outcomes. Accordingly, the available information supports a description of the study design and posted safety counts, but not a precise estimate of treatment effects or a conclusion about efficacy.
9. Statistical Methods Explained
The registry describes an early-phase dose-finding study in which the key objective is to identify a tolerable dose, rather than estimate a treatment effect against a control group. HCW9218 was administered at assigned dose levels in a single group. The record states that the dose-finding method was an adaptation of the continual reassessment method, beginning with cohorts of one patient. It does not report the full statistical plan, so the method can be explained only at a general level.
What dose finding is intended to do
In general, dose finding uses toxicity observations to guide which dose is assigned next and to estimate a dose that meets a tolerability target. Model-based approaches can use information across dose levels instead of treating each dose as unrelated. Their recommendations depend on choices made before the study, including the target toxicity level, model form, toxicity window, and rules for handling incomplete observations. These details are not reported in the registry record. The phrase “adaptation of the continual reassessment method” therefore identifies a broad approach, but not enough detail to reproduce the protocol’s decisions or assess its operating characteristics.
The registry says little to no toxicity was expected, but does not report a numeric target toxicity rate or the basis for that expectation. It also does not define dose-limiting toxicity in the posted record. Without those specifications, the listed dose levels and adverse-event counts cannot be used to independently determine the maximum tolerated dose. The registry does not report a selected dose or a dose-finding analysis.
Why the design limits comparisons
In general, randomization helps make treatment groups comparable on average. This study is listed as single-group, with allocation not applicable and no masking. It has no control arm, so there is no randomized estimate of how outcomes under HCW9218 compare with outcomes under another intervention or usual care. The dose-level groups are part of the dose-finding process, not randomized comparison groups. Any apparent variation across them may reflect participant characteristics, follow-up, or chance as well as dose. The record does not report enough information to adjust for those factors.
Small counts also limit precision. When few participants contribute to a dose-level count, a small change in the observed number can substantially alter the descriptive impression. In general, confidence intervals communicate the range of values reasonably compatible with the data under a specified analysis. The registry record does not report confidence intervals for the posted safety counts or primary outcome. Without such uncertainty measures, counts should be read as descriptive rather than as precise estimates.
What the secondary outcome labels can establish
The registry lists response categories of complete response, partial response, or stable disease, as well as progression-free survival and overall survival. In general, response outcomes summarize tumor status according to defined assessment criteria, while time-to-event outcomes concern time until a specified event. Analyses of time-to-event outcomes need rules for defining the event, censoring participants without an observed event, and specifying the time origin. The record does not report these definitions, assessment criteria, censoring rules, estimates, or analyses. The labels therefore establish which outcomes were planned or listed, not what the study found.
The registry reports zero analyses. That is a statement about the posted record, not proof that no analysis was performed outside it. No inferential test, model estimate, or analysis population is described in the record. Results should not be inferred from the study’s completion status or from the presence of secondary outcome names.
Planning illustrations and observed evidence
General sample-size planning asks how many participants or events might be needed to detect a specified effect under stated assumptions. The registry’s planning description characterizes its illustration as using an observed effect, two-sided significance level 0.05, equal allocation between two arms, and a normal approximation; it distinguishes event totals for time-to-event outcomes from participants per arm for other outcomes. These are described as planning assumptions, not as the design of this single-group dose-finding study. No planning values are reported in the registry record, and the record does not supply an observed effect estimate to interpret. Any sample-size illustration should therefore be treated as hypothetical planning, not as evidence that the study had a particular level of power or that an effect was observed.
In general, over-dispersion means that observed variation exceeds what a model assumes; if ignored, uncertainty can be understated. The registry record does not report an over-dispersion assessment or an analysis requiring one. More broadly, no statistical analysis details beyond the general dose-finding method are available, so readers should avoid attributing unreported modeling choices to the trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcome topics: response categories, progression-free survival, and overall survival. The response-rate description appears repeatedly, as do the survival outcome descriptions. The record does not explain whether these repetitions represent different assessments, timepoints, or analysis populations. It also does not report a hierarchy among the secondary outcomes or a multiplicity adjustment.
In general, testing multiple outcomes can increase the chance of finding an apparently notable result by chance if each is treated as an independent confirmatory test. A prespecified hierarchy or adjustment can address that issue, but the appropriate approach depends on the study’s objectives and analysis plan. The registry does not report such a plan, and no outcome analyses are listed. There are consequently no reported p-values or estimates from which to assess multiplicity in practice.
Missing-data handling is not reported in the registry record. The record does not say how missing tumor assessments, incomplete follow-up, or unavailable event times were treated. It also does not identify analysis populations, such as whether all enrolled participants or only participants with particular assessments were included in each outcome analysis. These omissions matter because outcome estimates can depend on who is included and how missing observations are handled.
Interim analyses, stopping rules beyond the general dose-finding description, and a complete statistical analysis plan are not reported in the registry record. The reported completion status does not supply those details. As a result, the registered outcome labels cannot be interpreted as evidence that all planned analyses were performed or that a particular multiplicity or missing-data strategy was used.
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 |
|---|---|---|---|
| HCW9218 Dose Level 1 | 2 | 3 | 66.7% |
| HCW9218 Dose Level 2 | 0 | 3 | 0.0% |
| HCW9218 Dose Level 3 | 0 | 3 | 0.0% |
| HCW9218 Dose Level 4 | 4 | 9 | 44.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| HCW9218 Dose Level 1 | 3 of 3 |
| HCW9218 Dose Level 2 | 3 of 3 |
| HCW9218 Dose Level 3 | 2 of 3 |
| HCW9218 Dose Level 4 | 6 of 9 |
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 |
|---|---|
| HCW9218 Dose Level 1 | 3 of 3 |
| HCW9218 Dose Level 2 | 3 of 3 |
| HCW9218 Dose Level 3 | 3 of 3 |
| HCW9218 Dose Level 4 | 9 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | HCW9218 Dose Level 1 | HCW9218 Dose Level 2 | HCW9218 Dose Level 3 | HCW9218 Dose Level 4 |
|---|---|---|---|---|---|
| Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Ascites | General disorders | 1 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Febrile Neutropenia | Infections and infestations | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Other, specify - C.Diff Infection | Infections and infestations | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Urinary Tract Obstruction | Infections and infestations | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Colonic obstruction - Partial bowel obstruction | Gastrointestinal disorders | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Thromboembolic event | Cardiac disorders | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
| Acute Kidney Injury | Renal and urinary disorders | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HCW9218 Dose Level 1 | HCW9218 Dose Level 2 | HCW9218 Dose Level 3 | HCW9218 Dose Level 4 |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | 3 of 3 | 3 of 3 | 3 of 3 | 9 of 9 |
| Lymphocyte count decreased | Investigations | 2 of 3 | 3 of 3 | 3 of 3 | 8 of 9 |
| Flu like symptoms | General disorders | 1 of 3 | 3 of 3 | 3 of 3 | 8 of 9 |
| Fever | General disorders | 1 of 3 | 1 of 3 | 2 of 3 | 8 of 9 |
| Anemia | Blood and lymphatic system disorders | 2 of 3 | 3 of 3 | 2 of 3 | 5 of 9 |
| Hyponatremia | Metabolism and nutrition disorders | 3 of 3 | 2 of 3 | 1 of 3 | 5 of 9 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 2 of 3 | 0 of 3 | 2 of 3 | 6 of 9 |
| Hypocalcemia | Metabolism and nutrition disorders | 1 of 3 | 1 of 3 | 2 of 3 | 6 of 9 |
| White blood cell decreased | Investigations | 0 of 3 | 1 of 3 | 3 of 3 | 5 of 9 |
| Activated partial thromboplastin time prolonged | Investigations | 2 of 3 | 0 of 3 | 1 of 3 | 5 of 9 |
Serious events with the highest arm-level rate: other (66.7%), ascites (33.3%), febrile neutropenia (11.1%), other, specify - c.diff infection (11.1%), urinary tract obstruction (11.1%).
The registry lists serious adverse event counts by dose level: 2 of 3 at level 1, 0 of 3 at level 2, 0 of 3 at level 3, and 4 of 9 at level 4. The counts for other adverse events are 3 of 3, 3 of 3, 3 of 3, and 9 of 9, respectively. These are descriptive counts within the listed dose groups. They do not provide a randomized comparison, and the registry record does not explain whether the dose groups had comparable participant characteristics or follow-up.
Deaths are listed as 3 at dose level 1, 3 at level 2, 2 at level 3, and 6 at level 4. The record does not report timing, cause, relationship to treatment, or the analytic context for these counts. They should not be interpreted as deaths caused by HCW9218.
The listed serious-event terms include Other at 66.7%, Ascites at 33.3%, and Febrile Neutropenia, Other, specify - C.Diff Infection, Urinary Tract Obstruction, and Colonic obstruction - Partial bowel obstruction at 11.1% each. The registry record does not provide further detail about the denominator or whether participants could contribute more than one term. These percentages should be read as registry-reported event-term summaries, not as a complete description of risk or causality.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed phase I, single-group study enrolled 18 participants to evaluate HCW9218 in select advanced solid tumors and had a dose-finding objective. It also reports the assigned dose levels and names an adaptation of the continual reassessment method. These design details show what the study set out to investigate, but they do not give the primary result.
The maximum tolerated dose is the stated primary objective, yet the registry record does not report the dose identified or the analysis supporting it. The secondary outcome listings name response, progression-free survival, and overall survival, but no corresponding estimates are reported. Without those results, the record cannot establish whether tumor responses occurred, how long participants remained progression-free, or how long they survived.
The safety counts provide descriptive information by dose level. They do not establish that an adverse event was caused by treatment, nor do they support a controlled comparison across dose levels. The record does not supply event timing, attribution, detailed definitions, or uncertainty estimates. A count in a dose group is not, by itself, a measure of comparative treatment effect.
These omissions do not mean that the study had no findings; they mean that the registry record does not report them in the information available for interpretation. Study completion is not a substitute for a posted result. Likewise, the presence of listed outcome names does not show that an outcome was measured successfully or that a particular result was obtained.
In general, an early-phase dose-finding study is not designed to provide the same kind of comparative evidence as a randomized trial. The single-group structure is suited to the stated dose-finding objective, but cannot distinguish treatment effects from other explanations for observed outcomes. The available record supports a cautious account of study design and listed safety data, not a conclusion about efficacy or a quantified comparison with an alternative.
13. Why This Trial Matters Statistically
This study illustrates an important distinction in clinical-trial statistics: a trial can have a clearly stated statistical objective without having a result available in its registry record. Here, the objective is to determine the maximum tolerated dose, and the record names a model-based dose-finding approach. Yet no selected dose or primary analysis is reported. For readers, separating the study question from the reported evidence is essential.
The design also shows why the analysis method must be interpreted in context. A continual reassessment approach is intended to guide dose assignment using accumulating toxicity information, but its operation depends on protocol choices that are not reported in the registry record. The method name alone does not reveal the target toxicity level, decision thresholds, or dose recommendation.
Safety counts illustrate another key principle: descriptive data are not automatically comparative evidence. The dose-level counts can describe what the registry lists, but the groups are not randomized controls and are small. Without event attribution, follow-up detail, and uncertainty estimates, contrasts across doses require caution.
Finally, named secondary outcomes should not be confused with posted results. The registry includes response and survival topics but reports no analyses. This makes transparent outcome reporting and a complete statistical analysis plan especially valuable: readers need estimates, definitions, analysis populations, missing-data rules, and uncertainty measures to evaluate how well the results answer the research questions.
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 registry record leaves important design and analysis details unavailable. It does not report a numeric maximum tolerated dose, dose-limiting toxicity definition, target toxicity level, detailed continual reassessment model, or final dose recommendation. Consequently, the primary dose-finding conclusion cannot be checked against the method description.
The study is single-group and unmasked, with no comparator arm. Dose-level groups are not randomized control groups, so their outcomes cannot provide a controlled estimate of dose effects. The registry reports enrollment of 18, but does not report the number evaluated for each efficacy outcome, participant-level follow-up, or reasons for any missing data.
Although response, progression-free survival, and overall survival are listed, their outcome definitions, assessment methods, timepoints, estimates, and analyses are not reported in the registry record. Multiplicity handling, analysis populations, interim analyses, and missing-data methods are also not reported. The registry lists zero analyses, which limits statistical interpretation of the posted outcomes.
The adverse-event summaries provide counts by dose level and selected serious-event terms, but the record does not report event timing, treatment attribution, detailed term-level denominators, or uncertainty estimates. Death counts are listed without cause or relationship to treatment. These limitations mean that the safety figures should remain descriptive and should not be used to infer causality or precise risks.
The planning description refers to a two-arm, equal-allocation illustration, whereas the registered trial is single-group. The record frames that illustration as planning rather than as the trial’s own design. No planning estimates are reported, and such illustrations cannot substitute for observed trial results or the missing primary analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: HCW9218 in Select Advanced Solid Tumors — NCT05322408.
- Registry record last updated 2025-11-05; status last verified 2025-10.
- Results first posted 2025-11-05.
- 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
NCT05322408 is a completed phase I, single-center, single-group dose-finding study of HCW9218 for select advanced solid tumors after at least two prior therapies. The registry reports enrollment of 18 and lists subcutaneous monotherapy at dose levels from 0.1 mg/kg to 1.2 mg/kg, administered once every 3 weeks. Allocation is not applicable and masking is none.
The primary objective was to determine the maximum tolerated dose using an adaptation of the continual reassessment method. The primary timeframe is through study completion, described as an average of 12 months. The record lists response, progression-free survival, and overall survival as secondary outcome topics, and includes adverse-event counts by dose level. It does not report the primary dose result, secondary outcome estimates, or statistical analyses. Details of missing-data handling, analysis populations, and multiplicity are not reported in the registry record.