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NCT06764771
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Conditions: Advanced Malignant Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 437
Sponsor: Bristol-Myers Squibb
Location: John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
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 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.
Source: ClinicalTrials.gov (NCT06764771). StuddyBuddy aggregates publicly available trial information.
