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
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