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  • NCT06997029

Not Yet Recruiting

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors - CA243-0001

Updated: 21 May, 2025   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Print this page CA243-0001
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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 13

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A Monotherapy Dose Escalation
Drug: BMS-986500
Experimental: Part 1B Combination Dose Escalation
Drug: BMS-986500, Palbociclib, Fulvestrant
Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
Drug: BMS-986500
Experimental: Part 2A Monotherapy Dose Expansion
Drug: BMS-986500
Experimental: Part 2B Combination Dose Expansion
Drug: BMS-986500, Palbociclib, Fulvestrant

Key Eligibility Criteria

Inclusion Criteria: - Participants must be ≥ 18 years of age. - Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. - Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1. - For Part 2A only, participants must have CCNE1-amplified ovarian cancer Exclusion Criteria: - Participants must not have an active brain metastasis. - Participants must not have impaired cardiac function or clinically significant cardiac disease. - Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months. - Participants must not have Grade ≥ 2 peripheral neuropathy. - Other protocol-defined Inclusion/Exclusion criteria apply.

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