Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05544929 | A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers | PHASE1 | ACTIVE NOT_RECRUITING | 126 | — | — | Oct 26, 2022 | Sep 1, 2027 | Jan 6, 2026 | 19 | United States, Canada +10 |
A DLT is defined as an adverse event or abnormal laboratory value that occurs during the DLT evaluation period where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications and meets the criteria defined in the study protocol
A DLT is defined as an adverse event or abnormal laboratory value that occurs during the DLT evaluation period where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications and meets the criteria defined in the study protocol
Incidence and severity of adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs
Number of dose interruptions of KFA115 and pembrolizumab, and number of dose reductions of KFA115
Dose intensity of KFA115 and pembrolizumab is defined as the ratio of actual cumulative dose received and actual duration of exposure
| Arm | Type | Description |
|---|---|---|
| Single-agent KFA115 | EXPERIMENTAL | KFA115 monotherapy |
| KFA115 run-in (1 cycle) + pembrolizumab | EXPERIMENTAL | 1-cycle KFA115 run-in followed by addition of pembrolizumab |
| KFA115 + pembrolizumab | EXPERIMENTAL | KFA115 + pembrolizumab combination given concurrently |
| Name | Type | Description |
|---|---|---|
| KFA115 | DRUG | Immunomodulatory agent |
| pembrolizumab | DRUG | Anti-PD-1 antibody |
Inclusion Criteria: * Non-small cell lung cancer with historic PD-L1 ≥ 1%, as determined locally using a clinically accepted assay. Patients must have experienced benefit from previous anti-PD(L)1-containing therapy for at least 4 months based on investigator-assessed disease stability or response ...