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RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests elironrasib and daraxonrasib alone and together in people with advanced solid tumors that have a gene change called KRAS G12C. It looks at safety, side effects, and how the body handles these drugs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 years old.
  • Have a solid tumor confirmed by lab testing with a KRAS G12C gene change. The cancer must be advanced or have spread and cannot be cured with treatment.
  • For Phase 1b dose testing: have a solid tumor that was treated before.
  • For later study groups: have non-small cell lung cancer previously treated with immune-based therapy, chemotherapy, and drugs called KRAS G12C (OFF) inhibitors; or have another eligible solid tumor treated before, but never with KRAS G12C (OFF) inhibitors.
  • Be fully active or able to do light work, even if heavy activity is limited.
  • Have organs that work well enough for the study.

Who can't join

  • Have cancer that started in the brain or spinal cord.
  • Have active cancer that has spread to the brain.
  • Have a known digestive problem that would change how your body absorbs the drugs.
  • Have had major surgery within 28 days before treatment, or a minor procedure not related to the study within 7 days before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (23)

CA

CO

FL

IN

MA

MI

NY

OK

PA

TN

TX

VA