Recruiting
Phase 1

BMS-986488

Sponsor:

Bristol-Myers Squibb

Code:

NCT06764771

Conditions

Advanced Malignant Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986488

Adagrasib

Cetuximab

Nivolumab

Study Details

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

Study ID

NCT06764771

Start date

Mar 25, 2025

Status verified date

Jul, 2026

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

437 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A: BMS-986488 Monotherapy

experimental: Part 1B: BMS-986488 + Adagrasib

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

experimental: Part 1D: BMS-986488 + Nivolumab

experimental: Part 2A: BMS-986488 Monotherapy

experimental: Part 2B: BMS-986488 + Adagrasib

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

experimental: Part 2D: BMS-986488 + Nivolumab

Interventions

BMS-986488

Specified dose on specified days

Adagrasib

Specified dose on specified days

Cetuximab

Specified dose on specified days

Nivolumab

Specified dose on specified days

Primary outcome measure

  • Number of participants with Adverse Events (AEs) [ Time Frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) ]
  • Number of participants with Serious AEs (SAEs) [ Time Frame: 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 [ Time Frame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days) ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) ]
  • Number of deaths [ Time Frame: From time of informed consent up to 52 weeks after end of treatment visit ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Martin Gutierrez, Site 0021

551-996-5863

The West Clinic, PLLC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Daniel Vaena, Site 0024

901-598-1454

BC Cancer Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Christian Kollmannsberger, Site 0032

6048776000

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Antoine Morin Coulombe, Site 0016

4185254444

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-07-29.