Approval Probability
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APR-246+ Pembrolizumab · 1 trial · 6 indications
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...
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APR-246 is an investigational small molecule being studied in oncology. It is being evaluated for use in acute myeloid leukemia, myelodysplastic syndromes, platinum sensitive recurrent high-grade serous ovarian cancer with mutated p53, bladder cancer, and other hematologic neoplasms. It is not approved and remains in clinical development.
APR-246 targets the p53 tumor suppressor protein. It is designed to reactivate mutant p53, restoring its tumor-suppressing function. This mechanism is being studied in cancers that carry p53 mutations, including high-grade serous ovarian cancer and TP53 mutant myelodysplastic syndromes.
APR-246 is being developed by Aprea Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol APRE. The company is conducting clinical trials of APR-246 across multiple oncology indications.
APR-246 has completed clinical trials ranging from Phase 1 to Phase 3. A Phase 2 study in platinum-resistant high-grade serous ovarian cancer has been completed, as has a Phase 3 study in TP53 mutant myelodysplastic syndromes. The drug remains investigational and is not FDA approved.
APR-246 has been studied in several completed trials. NCT00900614 was a Phase 1 safety study in refractory hematologic or prostate cancer. NCT02098343 was a Phase 1b/II study in recurrent ovarian cancer. NCT03268382 was a Phase 2 study in platinum-resistant ovarian cancer. NCT03745716 was a Phase 3 study in TP53 mutant MDS.
Yes, APR-246 is also known as eprenetapopt. This alternative name is used in some clinical and scientific literature. Both names refer to the same investigational small molecule being developed by Aprea Therapeutics for p53-mutant cancers.