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

NCT06764771 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CA234-0001
• Study Type: interventional
• Target: 437
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Advanced Malignant Tumors

Keywords

Colorectal Cancer; CRC; Renal Cell Carcinoma; RCC; Non-Small Cell Lung Cancer; NSCLC; Cancer; Oncology; Phase 1; Solid Tumor

Outcome Measures

Primary Outcomes (5)

• Number of participants with Adverse Events (AEs)

  Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

• Number of participants with Serious AEs (SAEs)

  Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

• Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria

  From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)

• Number of participants with AEs leading to discontinuation

  Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

• Number of deaths

  From time of informed consent up to 52 weeks after end of treatment visit

Secondary Outcomes (6)

• Maximum observed plasma concentration (Cmax)

  Until Cycle 4, Day 1 (1 Cycle = 28 Days)

• Time of maximum observed concentration (Tmax)

  Until Cycle 4, Day 1 (1 Cycle = 28 Days)

• Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

  Until Cycle 4, Day 1 (1 Cycle = 28 Days)

• Objective response rate (ORR)

  From time of informed consent up to 52 weeks after end of treatment visit

• Disease control rate (DCR)

  From time of informed consent up to 52 weeks after end of treatment visit

Study Arms (8)

Part 1A: BMS-986488 Monotherapy

EXPERIMENTAL

Drug: BMS-986488

Part 1B: BMS-986488 + Adagrasib

EXPERIMENTAL

Drug: BMS-986488; Drug: Adagrasib

Part 1C: BMS-986488 + Adagrasib + Cetuximab

EXPERIMENTAL

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

Part 1D: BMS-986488 + Nivolumab

EXPERIMENTAL

Drug: BMS-986488; Drug: Nivolumab

Part 2A: BMS-986488 Monotherapy

EXPERIMENTAL

Drug: BMS-986488

Part 2B: BMS-986488 + Adagrasib

EXPERIMENTAL

Drug: BMS-986488; Drug: Adagrasib

Part 2C: BMS-986488 + Adagrasib + Cetuximab

EXPERIMENTAL

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

Part 2D: BMS-986488 + Nivolumab

EXPERIMENTAL

Drug: BMS-986488; Drug: Nivolumab

Interventions

BMS-986488 DRUG

Specified dose on specified days

Part 1A: BMS-986488 Monotherapy; Part 1B: BMS-986488 + Adagrasib; Part 1C: BMS-986488 + Adagrasib + Cetuximab; Part 1D: BMS-986488 + Nivolumab; Part 2A: BMS-986488 Monotherapy; Part 2B: BMS-986488 + Adagrasib; Part 2C: BMS-986488 + Adagrasib + Cetuximab; Part 2D: BMS-986488 + Nivolumab

Adagrasib DRUG

Specified dose on specified days

Also known as: KRAZATI, BMS-986503, MRTX849

Part 1B: BMS-986488 + Adagrasib; Part 1C: BMS-986488 + Adagrasib + Cetuximab; Part 2B: BMS-986488 + Adagrasib; Part 2C: BMS-986488 + Adagrasib + Cetuximab

Cetuximab DRUG

Specified dose on specified days

Also known as: ERBITUX

Part 1C: BMS-986488 + Adagrasib + Cetuximab; Part 2C: BMS-986488 + Adagrasib + Cetuximab

Nivolumab DRUG

Specified dose on specified days

Also known as: OPDIVO, BMS-936558

Part 1D: BMS-986488 + Nivolumab; Part 2D: BMS-986488 + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Local Institution - 0021

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0020

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0024

Germantown, Tennessee, 38138, United States

Location

Local Institution - 0031

Brisbane, Queensland, 4029, Australia

Location

Local Institution - 0032

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0015

Montreal, Quebec, H2X 0A9, Canada

Location

Local Institution - 0016

Québec, Quebec, G1J 1Z4, Canada

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

adagrasib; Cetuximab; Nivolumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 8, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (3); CA (3); AU (1)