RecruitingPhase 1NCT06764771
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Sponsor
Bristol-Myers Squibb
Enrollment
437 participants
Start Date
Mar 25, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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 Criteria6
- 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).
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Interventions
DRUGBMS-986488
Specified dose on specified days
DRUGAdagrasib
Specified dose on specified days
DRUGCetuximab
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06764771
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