Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06764771

A 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Malignant Tumors Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0031, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986488

Drug

Specified dose on specified days

Adagrasib

Drug

Specified dose on specified days

Other names: KRAZATI, BMS-986503, MRTX849

Cetuximab

Drug

Specified dose on specified days

Other names: ERBITUX

Nivolumab

Drug

Specified dose on specified days

Other names: OPDIVO, BMS-936558

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Number of deaths

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

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)

  2. Time of maximum observed concentration (Tmax)

    Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)

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

    Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)

  4. Objective response rate (ORR)

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

    Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  5. Disease control rate (DCR)

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

    Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1

  6. Duration of response (DOR)

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

    Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.