Phase
Condition
Neoplasms
Treatment
Adagrasib
Cetuximab
Nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥ 18 years of age.
Histologically confirmed diagnosis of a locally advanced and unresectable ormetastatic 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 ductaladenocarcinoma (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) PerformanceStatus of 0 or 1.
Participants must have measurable disease per RECIST v1.1.
Exclusion
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.
Study Design
Connect with a study center
Local Institution - 0031
Brisbane, Queensland 4029
AustraliaSite Not Available
BC Cancer Vancouver
Vancouver, British Columbia V5Z 4E6
CanadaActive - Recruiting
Local Institution - 0032
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Local Institution - 0015
Montréal, Quebec H2X 0A9
CanadaSite Not Available
Local Institution - 0016
Quebec City, Quebec G1J 1Z4
CanadaSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Local Institution - 0021
Hackensack, New Jersey 07601
United StatesSite Not Available
Local Institution - 0020
Allentown, Pennsylvania 18103
United StatesSite Not Available
Local Institution - 0024
Germantown, Tennessee 38138
United StatesSite Not Available
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38138
United StatesActive - Recruiting
Local Institution - 0025
Dallas, Texas 75390
United StatesSite Not Available
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