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

Recruiting now · Phase 1

Conditions studied: Solid Tumor

In brief

This is a Phase 1, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic Solid Tumors

Key facts

Study ID

NCT06874335

Run by

Biohaven Therapeutics Ltd.

People needed

140

Starts

2025-03-20

Expected to finish

2029-03-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
• Age greater than or equal to 18 years
• 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.
• Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
• Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
• Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 monotherapy):
• 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.
• Tumors originating from the salivary glands, or unknown primary sites are not eligible.
• Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
• Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 in combination with cemiplimab):
• 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.
• Tumors originating from the salivary glands, or unknown primary sites are not eligible.
• Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
• Participants must have received ≤ 2 prior lines of systemic anti-cancer therapy which may include at most one prior anti-programmed cell death protein 1 (PD-1) (programmed death-ligand 1 [PD-L1]) therapy for advanced/metastatic disease.
• Dose Optimization Cohorts (BHV-1530 monotherapy):
• oParticipants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra)..
• Measurable advanced or metastatic tumors per RECIST 1.1 criteria
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Acceptable liver function:
• Bilirubin ≤ 1.5 × upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤3×ULN may be enrolled.
• AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)
• Acceptable renal function:
• Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is >1.5 × ULN; 24-hour urine collection is allowed, but not required
• Acceptable hematologic status:
• Blood transfusion or growth factor support is not allowed within 7 days prior to blood samples that will be used to establish eligibility

Where it is running

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

Full record on ClinicalTrials.gov

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