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
Erasca, Inc.
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. ERAS-0015 will be given alone or in combination with other treatments.
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 optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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, hemato…
Interventions
- DrugERAS-0015
ERAS-0015 Administered orally
- DrugERAS-0015 in combination
ERAS-0015 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Locations (5)
- Florida Cancer SpecalistsSarasota, Florida
- Memorial Sloan Kettering Cancer CenterNew York, New York
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- University of Texas at TylerTyler, Texas
- NEXT VirginiaFairfax, Virginia