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Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

NCT06128551

RecruitingPhase 1, Phase 2

Sponsor: Revolution Medicines, Inc.

Conditions: Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer, Pancreatic Ductal Adenocarcinoma

Interventions: Elironrasib, Daraxonrasib

Countries: United States, France, Germany, Italy, Netherlands, Puerto Rico, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (55)
  • Duarte, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Grand Rapids, Michigan, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Oklahoma City, Oklahoma, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Irving, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
  • Angers, France
  • Bordeaux, France
  • Bron, France
  • Lille, France
  • Lyon, France
  • Montpellier, France
  • Nantes, France
  • + 25 more on CT.gov