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A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of PBI-410 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

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Trial Profile

A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of PBI-410 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Jan 2026

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At a glance

  • Drugs BHV 1510 (Primary) ; Cemiplimab (Primary)
  • Indications Endometrial cancer; Non-small cell lung cancer; Solid tumours; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Biohaven Therapeutics; Pyramid Biosciences

Most Recent Events

  • 11 Dec 2025 According to a Biohaven Therapeutics media release, as of the clinical cutoff date, a total of 31 participants were treated with the combination of BHV-1510 and cemiplimab. BHV-1510 doses ranged from 2-2.75 mg/kg Q3W and 1.25-1.5 mg/kg D1D8Q3W, while cemiplimab was administered at 350 mg Q3W.
  • 11 Dec 2025 According to a Biohaven Therapeutics media release, Ida Micaily, M.D., M.S., Assistant Professor at the Sidney Kimmel Comprehensive Cancer Center at Jefferson, is the Principal Investigator of the trial.
  • 11 Dec 2025 According to a Biohaven Therapeutics media release, clinical safety and efficacy data for BHV-1510 will be presented at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress, taking place December 10-12, 2025, in London, United Kingdom

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