ERAS-4001 for advanced or metastatic solid tumors with KRAS mutations.
A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors
PHASE1 · Erasca, Inc. · NCT07021898
This trial will try the oral drug ERAS-4001, alone or with other cancer therapies, in adults with advanced or metastatic solid tumors that have specific KRAS mutations.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Erasca, Inc. (industry) |
| Drugs / interventions | radiation |
| Locations | 5 sites (Nashville, Tennessee and 4 other locations) |
| Trial ID | NCT07021898 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, Phase 1/1b, open-label, multicenter dose-finding study of ERAS-4001 given as monotherapy and in combination with other cancer treatments. The study begins with dose optimization of ERAS-4001 alone and then proceeds to dose-finding for ERAS-4001 combined with other therapies. Eligible patients are adults with advanced or metastatic solid tumors harboring specified KRAS mutations and adequate organ function and performance status. Primary objectives focus on safety, tolerability, and identifying recommended doses, with exploratory measures of antitumor activity.
Who should consider this trial
Good fit: Adults (≥18) with advanced or metastatic solid tumors that carry the specified KRAS mutations, ECOG performance status 0–1, adequate organ function, able to take oral medication, and without effective or tolerable standard systemic options are the ideal candidates.
Not a fit: Patients with ECOG >1, prior treatment with a RAS inhibitor, an available effective standard therapy, or recent participation in another investigational treatment are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, ERAS-4001 could become a new targeted option for people with KRAS-mutant advanced solid tumors and help control disease when standard treatments are not available or effective.
How similar studies have performed: There have been recent successes targeting specific KRAS mutations (for example KRAS G12C), but many RAS alterations remain difficult to target, so ERAS-4001 is a novel, early-phase approach building on partial precedents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Willing and able to give written informed consent * Pathological documentation of tumor type and mutation prior to the first dose of study drug(s) * There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy * Able to swallow oral medication * Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * Adequate cardiovascular, hematological, liver, and renal function * Willing to comply with all protocol-required visits, assessments, and procedures Exclusion Criteria: * Previous treatment with a RAS inhibitor * Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001 * Received prior palliative radiation within 14 days of Cycle 1, Day 1 * Have primary central nervous system (CNS) tumors * Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption * Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs * Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial
Where this trial is running
Nashville, Tennessee and 4 other locations
- Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- NEXT Oncology — Irving, Texas, United States (RECRUITING)
- NEXT Oncology — San Antonio, Texas, United States (RECRUITING)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Erasca Clinical Team
- Email: clinicaltrials@erasca.com
- Phone: +1-858-465-6511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Solid Tumors, Solid Tumor, Advanced Solid Tumor, Solid malignancies, Targeted therapy, Molecular alterations, pembrolizumab, Keytruda