Testing ERAS-0015 in patients with advanced solid tumors
A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors
This study is testing a new drug called ERAS-0015 to see if it is safe and effective for people with advanced solid tumors that have certain RAS mutations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Erasca, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Sarasota, Florida and 4 other locations) |
| Trial ID | NCT06983743 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of ERAS-0015 in patients with advanced or metastatic solid tumors that have specific RAS mutations. It is a first-in-human, Phase 1/1b, open-label, multicenter study that begins with dose optimization of ERAS-0015 as a standalone treatment, followed by its use in combination with other cancer therapies. The study aims to determine the optimal dosing and assess the drug's effectiveness in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors and specific RAS mutations who have no effective standard treatment options.
Not a fit: Patients who have previously been treated with a RAS inhibitor or are currently receiving another investigational therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new targeted therapy option for patients with advanced solid tumors that have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting specific mutations in solid tumors have shown promise in the past.
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), for applicable cohorts. * 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-0015 * 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
Sarasota, Florida and 4 other locations
- Florida Cancer Specalists — Sarasota, Florida, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- University of Texas at Tyler — Tyler, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Erasca Clinical Team 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.