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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06260514 | Study of APR-1051 in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | 90 | — | — | Jun 13, 2024 | Jun 1, 2028 | Apr 23, 2026 | 3 | United States |
* Part 1 dose escalation: Incidence of adverse Events (AE), serious AEs (SAE), treatment-related AEs, AEs that would qualify as a dose-limiting toxicity (DLT), changes in clinical laboratory values, vital signs, ECG, ECHO * Part 1 dose escalation: Severity of adverse Events (AE), serious AEs (SAE), treatment-related AEs, and changes in clinical laboratory values, vital signs, ECG, ECHO according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
•Part 1 dose escalation: Recommended Phase 2 Dose (RP2D) of APR-1051 monotherapy \[Time frame: Day 1 through to start of dose expansion phase\]. The RP2D of will be determined based on review of safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data
| Arm | Type | Description |
|---|---|---|
| APR-1051 | EXPERIMENTAL | Dose Escalation based on BOIN Design |
| Name | Type | Description |
|---|---|---|
| APR-1051 | DRUG | WEE1 Inhibitor |
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of advanced/metastatic solid tumor * Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |