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Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
RECRUITINGPhase 1/2Sponsored by Revolution Medicines, Inc.
Actively Recruiting
PhasePhase 1/2
SponsorRevolution Medicines, Inc.
Started2023-11-14
Est. completion2028-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations21 sites
View on ClinicalTrials.gov →
NCT06128551
Summary
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 18 years of age * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. Phase 1b Dose Escalation: solid tumors, previously treated 2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors. * ECOG performance status 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active brain metastases * Known impairment of GI function that would alter the absorption * Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Conditions5
CancerColorectal CancerLung CancerNon-small Cell Lung Cancer (NSCLC)Pancreatic Ductal Adenocarcinoma
Interventions2
Locations21 sites
City of Hope
UC IRVINE Health
UC Davis Comprehensive Cancer Center
Stanford Cancer Institute
University of Colorado Cancer Center
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 1/2
SponsorRevolution Medicines, Inc.
Started2023-11-14
Est. completion2028-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations21 sites
View on ClinicalTrials.gov →
NCT06128551