A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors

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.

Interventions

• ERAS-0015 · DRUG

  ERAS-0015 Administered orally

• ERAS-0015 in combination · DRUG

  ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (9)

• Providence Medical Group, Santa Rosa, California · Recruiting
• University of Colorado, Aurora, Colorado · Recruiting
• Florida Cancer Specalists, Sarasota, Florida · Recruiting
• Moffitt Cancer Center, Tampa, Florida · Recruiting
• Massachusetts General Hospital (MG), Boston, Massachusetts · Recruiting
• Memorial Sloan Kettering Cancer Center, New York, New York · Recruiting
• The University of Texas MD Anderson Cancer Center, Houston, Texas · Recruiting
• University of Texas at Tyler, Tyler, Texas · Recruiting
• NEXT Virginia, Fairfax, Virginia · Recruiting