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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

Locations21 sites

City of Hope
Duarte, California, 91010
UC IRVINE Health
Orange, California, 92868
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Stanford Cancer Institute
Stanford, California, 94305
University of Colorado Cancer Center
Aurora, Colorado, 80045

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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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