A Phase 1 Study of BHV-1530 in Advanced Solid Tumors (NCT06874335)

🧪 Interventions in This Study

• BHV-1530 (DRUG)
• Cemiplimab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 their last anticancer therapy and within 90 days of the start of study treatment. An older archival sample may be acceptable with Sponsor approval.
4. Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
5. Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
6. Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 monotherapy):
7. Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) of the oral cavity, hypopharynx, oropharynx, nasopharynx, larynx and sinonasal tract.
8. Tumors originating from the salivary glands, or unknown primary sites are not eligible.
9. Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
10. Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 in combination with cemiplimab):
11. Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) of the oral cavity, hypopharynx, oropharynx, nasopharynx, larynx and sinonasal tract.
12. Tumors originating from the salivary glands, or unknown primary sites are not eligible.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

• Site-111 — Newport Beach, California
• Site-107 — Denver, Colorado
• Site-108 — Lake Mary, Florida
• Site-121 — Miami, Florida
• Site-118 — Orlando, Florida
• Site-120 — Ann Arbor, Michigan
• Site-110 — Detroit, Michigan
• Site-115 — Durham, North Carolina
• Site-122 — Cleveland, Ohio
• Site-112 — Myrtle Beach, South Carolina
• Site-116 — Nashville, Tennessee
• Site-103 — Austin, Texas
• Site-104 — Houston, Texas
• Site-101 — Irving, Texas
• Site-105 — San Antonio, Texas
• Site-106 — West Valley City, Utah
• Site-102 — Fairfax, Virginia

📞 Contact the Study Coordinator

Phone: (203) 404-0410

Email: clinicaltrials@biohavenpharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.