Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AMB302
BHV-1530 · 1 trial · 1 indication
Incidence and severity of TEAEs, including DLTs, SAEs and change from baseline for laboratory values, electrocardiograms (ECGs), vital signs, and physical exams to determine the safety profile, MTD, MRAD and RDR of BHV-1530 monotherapy and in combination with cemiplimab.
Incidence and severity of treatment-emergent AEs and SAEs, changes between baseline and postbaseline in laboratory values, ECGs, vital signs, and physical exams.
| Arm | Type | Description |
|---|---|---|
| BHV-1530 Monotherapy | EXPERIMENTAL | - |
| Experimental: BHV-1530 in combination with Cemiplimab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BHV-1530 | DRUG | BHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle |
| Cemiplimab | DRUG | cemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle |
Inclusion Criteria: 1. Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent 2. Age greater than or equal to 18 years 3. Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BHV-1530 is an investigational small molecule drug being developed by Biohaven Ltd. for the treatment of advanced solid tumors. It is a targeted oncology therapy designed to inhibit FGFR3, a receptor tyrosine kinase. BHV-1530 is currently in Phase 1 clinical development and is not yet approved for any indication.
BHV-1530 is being studied for use in patients with advanced solid tumors. The Phase 1 trial enrolls adults with solid tumors, and the study is biomarker-selected, meaning patients are chosen based on specific molecular characteristics. It is investigational and has not been approved for any use.
BHV-1530 targets FGFR3, a receptor tyrosine kinase that is part of the fibroblast growth factor receptor family. By inhibiting FGFR3, the drug aims to interfere with signaling pathways that drive tumor growth in cancers with FGFR3 alterations. This makes it a targeted small molecule therapy.
BHV-1530 is being developed by Biohaven Ltd., a clinical-stage biopharmaceutical company. Biohaven trades on the New York Stock Exchange under the ticker symbol BHVN. The company is advancing BHV-1530 as part of its oncology pipeline.
BHV-1530 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is designed to evaluate the drug in patients with advanced solid tumors, and it is currently recruiting participants.
BHV-1530 is being evaluated in one active clinical trial, NCT06874335, titled A Phase 1 Study of BHV-1530 in Advanced Solid Tumors. The trial is recruiting up to 140 adult patients in the United States and is controlled, though it is not randomized or double-blinded.