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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)

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 10
    Locations
  • BMS Recruiting Study icon
    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 or in combination by participants with ccRCC.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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. Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI).
          1. Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
            1. Eastern Cooperative Oncology Group performance status of 0 to 1.

              Exclusion Criteria

              Exclusion Criteria Icon
              • Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
                1. 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. Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).
                    1. Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).
                      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.
                          1. Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.
                            Additional Information *
                            • Other protocol-defined Inclusion/Exclusion criteria apply.

                              Treatment Options

                              Study Arms

                              ASSIGNED INTERVENTION

                              Study Arms

                              Experimental: Part 1A BMS-986506 Monotherapy Escalation

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986506

                              Study Arms

                              Experimental: Part 2A BMS-986506 Monotherapy Expansion

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986506

                              Study Arms

                              Experimental: Part 2B BMS-986506 Monotherapy Expansion

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986506

                              Study Arms

                              Experimental: Part 3A BMS-986506 + Pumitamig Combination Dose Escalation

                              ASSIGNED INTERVENTION
                              • Drug: Pumitamig, BMS-986506

                              Study Arms

                              Experimental: Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation

                              ASSIGNED INTERVENTION
                              • Drug: Pumitamig, Ipilimumab, BMS-986506

                              Study Arms

                              Experimental: Part 4A BMS-986506 + Pumitamig Combination Dose Expansion

                              ASSIGNED INTERVENTION
                              • Drug: Pumitamig, BMS-986506

                              Study Arms

                              Experimental: Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion

                              ASSIGNED INTERVENTION
                              • Drug: Pumitamig, Ipilimumab, BMS-986506
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