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Association details:
Biomarker:KRAS G12C
Cancer:Solid Tumor
Drug:divarasib (RG6330) (KRAS G12C inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Excerpt:
...- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation

Published date:
08/24/2023
Excerpt:
Among patients with NSCLC, a confirmed response was observed in 53.4% of patients (95% confidence interval [CI], 39.9 to 66.7), and the median progression-free survival was 13.1 months (95% CI, 8.8 to could not be estimated). Among patients with colorectal cancer, a confirmed response was observed in 29.1% of patients (95% CI, 17.6 to 42.9), and the median progression-free survival was 5.6 months (95% CI, 4.1 to 8.2). Responses were also observed in patients with other solid tumors....Treatment with divarasib resulted in durable clinical responses across KRAS G12C–positive tumors, with mostly low-grade adverse events.
DOI:
10.1056/NEJMoa2303810
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

459MO - Phase Ia study to evaluate GDC-6036 monotherapy in patients with solid tumors with a KRAS G12C mutation

Published date:
09/05/2022
Excerpt:
GDC-6036 demonstrated an acceptable safety profile, a PK profile compatible with once-daily dosing, and encouraging efficacy in pts with pretreated oST with a KRAS G12C mutation.
Trial ID: