Testing BMS-986488 for 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 study is testing a new treatment called BMS-986488 to see if it can help people with advanced cancers feel better and fight their disease, either on its own or with other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 437 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bristol-Myers Squibb (industry)
• Locations: 8 sites (Hackensack, New Jersey and 7 other locations)
• Trial ID: NCT06764771 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and anti-cancer activity of BMS-986488, both as a standalone treatment and in combination with other therapies, in patients with advanced malignant tumors. Participants will include those with various types of cancers, including colorectal cancer, renal cell carcinoma, and non-small cell lung cancer. The study aims to determine the effectiveness of this experimental treatment in managing these serious conditions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific advanced solid tumors, particularly those with KRAS G12C mutations.

Not a fit: Patients with untreated central nervous system metastases or significant cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced malignant tumors, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Hackensack, New Jersey and 7 other locations

• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)
• Local Institution - 0020 — Allentown, Pennsylvania, United States (NOT_YET_RECRUITING)
• The West Clinic, PLLC dba West Cancer Center — Germantown, Tennessee, United States (RECRUITING)
• Local Institution - 0025 — Dallas, Texas, United States (NOT_YET_RECRUITING)
• Local Institution - 0031 — Brisbane, Queensland, Australia (NOT_YET_RECRUITING)
• BC Cancer Vancouver — Vancouver, British Columbia, Canada (RECRUITING)
• Local Institution - 0015 — Montréal, Quebec, Canada (NOT_YET_RECRUITING)
• Local Institution - 0016 — Quebec City, Quebec, Canada (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Conditions: Advanced Malignant Tumors, Colorectal Cancer, CRC, Renal Cell Carcinoma, RCC, Non-Small Cell Lung Cancer, NSCLC, Cancer