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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: Nivolumab; Drug: BMS-986488; Drug: Cetuximab; Drug: Adagrasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06764771

CA234-0001

Details and patient eligibility

About

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.

Enrollment: 437 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) or clear-cell ovarian cancer (ccOC).

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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437 participants in 8 patient groups

Part 1A: BMS-986488 Monotherapy

Experimental group

Treatment:

Drug: BMS-986488

Part 1B: BMS-986488 + Adagrasib

Experimental group

Treatment:

Drug: Adagrasib

Drug: BMS-986488

Part 1C: BMS-986488 + Adagrasib + Cetuximab

Experimental group

Treatment:

Drug: Adagrasib

Drug: Cetuximab

Drug: BMS-986488

Part 1D: BMS-986488 + Nivolumab

Experimental group

Treatment:

Drug: BMS-986488

Drug: Nivolumab

Part 2A: BMS-986488 Monotherapy

Experimental group

Treatment:

Drug: BMS-986488

Part 2B: BMS-986488 + Adagrasib

Experimental group

Treatment:

Drug: Adagrasib

Drug: BMS-986488

Part 2C: BMS-986488 + Adagrasib + Cetuximab

Experimental group

Treatment:

Drug: Adagrasib

Drug: Cetuximab

Drug: BMS-986488

Part 2D: BMS-986488 + Nivolumab

Experimental group

Treatment:

Drug: BMS-986488

Drug: Nivolumab