A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Sponsored by Erasca, Inc.
About this study
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.
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.
Where this study is enrolling
- Call 877-632-6789
The University of Texas MD Anderson Cancer Center
Houston, Texas
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Who can participate
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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
- ✓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
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Trial data sourced from ClinicalTrials.gov.