Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BHV-1510 · 1 trial · 1 indication
Description: Incidence and severity of AEs, serious adverse events (SAEs) and dose limiting toxicities (DLTs). Severity of AEs will be assessed according to the NCI CTCAE v5.0. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.
Based on tolerability and preliminary antitumor activity. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Incidence and severity of AEs, SAEs and DLTs. Severity of AEs will be assessed according to the NCI CTCAE v5.0
Assessed by RECIST v 1.1
| Arm | Type | Description |
|---|---|---|
| BHV-1510 Monotherapy Dose Escalation | EXPERIMENTAL | - |
| BHV-1510 in combination with Cemiplimab dose escalation | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BHV-1510 | DRUG | BHV-1510 will be administered on Day 1 every 3 weeks |
| Cemiplimab | DRUG | cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks |
Key Inclusion Criteria: * Male or female participants aged ≥18 years. * Unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumor that is refractory to standard therapies, or has no approved standard therapies, or no approved standard therapies at its current treatment s...
| 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 |
BHV-1510 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, and the drug is being studied in patients with advanced solid tumors. BHV-1510 is not yet approved by the FDA and remains in clinical trials.
BHV-1510 targets Trop2, a protein that is overexpressed in many solid tumors. By targeting Trop2, the drug aims to interfere with tumor growth. This mechanism is being evaluated in a Phase 1/2 clinical trial for advanced solid tumors.
BHV-1510 is being developed by Biohaven Ltd., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of BHV-1510 in patients with solid tumors. Biohaven is listed on the stock exchange under the ticker symbol BHVN.
BHV-1510 is in Phase 1 clinical development. The drug is being studied in a Phase 1/2 trial for advanced solid tumors, and the trial is currently recruiting participants. BHV-1510 is an investigational drug and has not been approved by regulatory authorities.
BHV-1510 is being studied in a Phase 1/2 clinical trial with the identifier NCT06384807. This trial is recruiting patients with advanced solid tumors in the United States, with an enrollment target of 500 participants. The study is open to adults aged 18 years and older.
Yes, BHV-1510 was previously known as PBI-410. The clinical trial NCT06384807, titled 'A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors,' confirms that the drug was renamed. Both names refer to the same investigational small molecule targeting Trop2.