RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Erasca, Inc.,

Study Record Dates

2028-12-01