A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Recruiting · NCT06764771 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
8 locations listed across 4 US states.
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey, United States
- Local Institution - 0020 - Allentown, Pennsylvania, United States
- The West Clinic, PLLC dba West Cancer Center - Germantown, Tennessee, United States
- Local Institution - 0025 - Dallas, Texas, United States
- BC Cancer Vancouver - Vancouver, British Columbia, Canada
- Local Institution - 0015 - Montreal, Quebec, Canada
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus - Québec, Quebec, Canada
- Local Institution - 0031 - Brisbane, Queensland, Australia