BMS CA234-0001 MalignantTumor

Full Clinical Trial Name

BMS CA234-0001 A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants with Advanced Malignant Tumors

Clinical Trial

  • Cancer

Phase

Phase
1

Patient Type

Adult
Doctor(s) running this study

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

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.

Doctor(s) running this study