RECRUITING

A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

Conditions

Metastatic Solid Tumors Solid Tumor Advanced Solid Tumor Solid malignancies Targeted therapy Molecular alterations pembrolizumab Keytruda panitumumab Vectibix Metastatic solid tumor Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.

Official Title

A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2025-08

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07021898

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.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) * 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-4001 * 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

Inclusion Criteria

Exclusion 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)
* 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-4001
* 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

Contacts and Locations

Study Contact

Erasca Clinical Team

CONTACT

+1-858-465-6511

clinicaltrials@erasca.com

Les Brail, Study Director, PhD

CONTACT

Principal Investigator

Gerri Lee

STUDY_DIRECTOR

Erasca, Inc.

Study Locations (Sites)

NEXT Oncology

Irving, Texas, 75039

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Erasca, Inc.

Gerri Lee, STUDY_DIRECTOR, Erasca, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-08

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

Solid Tumor
Advanced Solid Tumor
Solid malignancies
Targeted therapy
Molecular alterations
pembrolizumab
Keytruda
panitumumab
Vectibix
Metastatic solid tumor
Neoplasms

Additional Relevant MeSH Terms

Metastatic Solid Tumors