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Trial ID CA242-0001  |   NCT07195682

A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 9
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
    1. For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
      1. For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
        1. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Participants with Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
            1. For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
              1. Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
                1. Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: BMS-986506: Part 1A

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986506

                    Study Arms

                    Experimental: BMS-986506: Part 2A

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986506

                    Study Arms

                    Experimental: BMS-986506: Part 2B

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986506
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