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Active (not recruiting) Phase 1 NCT06764771

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advanced Malignant Tumors

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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 participate
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.
Locations 3
Australia (1)
Local Institution - 0031
Brisbane , Queensland
Canada (1)
Local Institution - 0032
Vancouver , British Columbia
United States (1)
Local Institution - 0021
Hackensack , New Jersey
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.03.2025
Completion date
15.10.2027
Registry ID
NCT06764771
Source
anzctr
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