
BMS CA234-0001 MalignantTumor
Full Clinical Trial Name
Clinical Trial
- Cancer
Phase
Patient Type
Description
The 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
- 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.
- 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.
Doctor(s) running this study
