Status:
RECRUITING
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Erasca, Inc.
Conditions:
Metastatic Solid Tumors
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. E...
Detailed Description
This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimizatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06983743
Start Date
June 5 2025
End Date
December 1 2028
Last Update
September 11 2025
Active Locations (5)
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1
Florida Cancer Specalists
Sarasota, Florida, United States, 34232
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
University of Texas at Tyler
Tyler, Texas, United States, 75701