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Trial ID CA234-0001  |   NCT06764771

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 8
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participant must be ≥ 18 years of age.
    1. Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
      1. Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
        1. Parts 2A, 1D, 2D: ccRCC.
          1. Part 1B: solid tumors with KRAS G12C mutation.
            1. Part 2B: NSCLC with KRAS G12C mutation.
              1. Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
              2. Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
                1. Participants must have measurable disease per RECIST v1.1.

                  Exclusion Criteria

                  Exclusion Criteria Icon
                  :
                  • Untreated central nervous system (CNS) metastases.
                    1. Leptomeningeal metastasis (carcinomatous meningitis).
                      1. Impaired cardiac function or clinically significant cardiac disease.
                        1. For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.
                          1. History of pneumonitis or interstitial lung disease (ILD).
                            1. History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
                            2. Other protocol-defined inclusion/exclusion criteria apply.
                              Additional Information *

                              Treatment Options

                              Study Arms

                              ASSIGNED INTERVENTION

                              Study Arms

                              Experimental: Part 1A: BMS-986488 Monotherapy

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488

                              Study Arms

                              Experimental: Part 1B: BMS-986488 + Adagrasib

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488, Adagrasib

                              Study Arms

                              Experimental: Part 1C: BMS-986488 + Adagrasib + Cetuximab

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488, Adagrasib, Cetuximab

                              Study Arms

                              Experimental: Part 1D: BMS-986488 + Nivolumab

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488, Nivolumab

                              Study Arms

                              Experimental: Part 2A: BMS-986488 Monotherapy

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488

                              Study Arms

                              Experimental: Part 2B: BMS-986488 + Adagrasib

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488, Adagrasib

                              Study Arms

                              Experimental: Part 2C: BMS-986488 + Adagrasib + Cetuximab

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488, Adagrasib, Cetuximab

                              Study Arms

                              Experimental: Part 2D: BMS-986488 + Nivolumab

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986488, Nivolumab
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