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

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

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.

Inclusion Criteria:

• Participant must be ≥ 18 years of age.

• Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.

• 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).

• Parts 2A, 1D, 2D: ccRCC.

  i) Part 1B: solid tumors with KRAS G12C mutation.

ii) Part 2B: NSCLC with KRAS G12C mutation.

iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.

• Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
• Participants must have measurable disease per RECIST v1.1.

Exclusion Criteria:

• Untreated central nervous system (CNS) metastases.

• Leptomeningeal metastasis (carcinomatous meningitis).

• Impaired cardiac function or clinically significant cardiac disease.

• For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.

  i) History of pneumonitis or interstitial lung disease (ILD).

ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

- Other protocol-defined inclusion/exclusion criteria apply.