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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 - your organs (liver, kidneys, etc.) are working well enough based on blood tests Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Elironrasib

oral tablets

DRUG

Daraxonrasib

oral tablets

Locations (20)

City of Hope
Duarte, California, United States
UC IRVINE Health
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford Cancer Institute
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Cancer
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Columbia University
New York, New York, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institue
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT Oncology San Antonio
San Antonio, Texas, United States
START Texas
San Antonio, Texas, United States