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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03409458 | A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab | PHASE1 | COMPLETED | 68 | — | — | Apr 24, 2018 | Aug 31, 2022 | Nov 18, 2023 | 6 | United States, Switzerland |
| Arm | Type | Description |
|---|---|---|
| PT-112 in combination with avelumab | EXPERIMENTAL | PT-112, administered by intravenous infusion avelumab, administered by intravenous infusion Patients with all listed conditions are eligible for treatment during the dose escalation phase of the study. Patients with NSCLC are eligible for the dose confirmation phase of the study. |
| Name | Type | Description |
|---|---|---|
| PT-112 | DRUG | The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort. For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15. |
| avelumab | BIOLOGICAL | Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15. |
Key Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients ...