Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APR-1051 · 1 trial · 1 indication
* 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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
APR-1051 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
APR-1051 targets WEE1, a kinase involved in cell cycle regulation. By inhibiting WEE1, the drug aims to disrupt cancer cell division and growth, though its full mechanism and efficacy are still being studied in clinical trials.
APR-1051 is being developed by Aprea Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol APRE.
APR-1051 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being evaluated for safety and efficacy in patients.
APR-1051 is being studied in a Phase 1 clinical trial with the identifier NCT06260514. This trial is recruiting patients with advanced solid tumors in the United States and aims to enroll approximately 90 participants aged 18 years and older.
No alternative names for APR-1051 have been reported. It is a distinct investigational compound developed by Aprea Therapeutics, Inc., and is not known to be identical to any other marketed or investigational drug.