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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04383938 | Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies | PHASE1 | COMPLETED | 40 | — | — | Jun 25, 2020 | Apr 30, 2022 | May 13, 2025 | 8 | United States |
To determine the Frequency of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) related to APR-246 in combination with pembrolizumab.
To determine the dose of APR-246 to be selected for the expansion phase based on the occurence of dose limiting toxicities (DLTs) experienced during the safety assessment period
| Arm | Type | Description |
|---|---|---|
| Safety Lead In-Phase 1 Dose Level 1 | EXPERIMENTAL | APR-246 4.5g/d with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced non-CNS primary tumors |
| Expansion 1- Gastric Cancer | EXPERIMENTAL | APR-246 4.5 g/d (days 1-4) with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced gastric or GEJ tumors |
| Expansion 2- Bladder Cancer | EXPERIMENTAL | APR-246 4.5 g/d (days 1-4) with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced bladder or urothelial tumors |
| Expansion 3 -NSCLC | EXPERIMENTAL | APR-246 4.5 g/d (days 1-4) with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced NSCLC. |
| Name | Type | Description |
|---|---|---|
| APR-246 (eprenetapopt) + Pembrolizumab | DRUG | APR-246 D1-4 + Pembrolizumab D3 |
Inclusion Criteria: 1. Signed informed consent form (ICF) and ability to comply with protocol requirements. 2. Known tumor TP53 mutation status from recent or archival sample. 3. Histologically and/or cytologically confirmed solid tumor malignancy 1. Safety lead in- Advanced non-central nervous...