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A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies

A Phase 1b/2 Study of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Gastrointestinal Malignancies (HERKULES-3)

NCT05039177•Erasca, Inc.

View on ClinicalTrials.gov

Summary

* To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced GI malignancies. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies. * To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination.

Detailed Description

This is a Phase 1b/2, open-label, multicenter clinical study evaluating ERAS-007 in combination with other cancer therapies in study participants with GI malignancies. This study will serve as a platform study, allowing for evaluation of safety/tolerability and efficacy of ERAS-007 in combination with other cancer therapies. The study will initially commence with dose escalation of ERAS-007 administered in combination with encorafenib and cetuximab in study participants with metastatic colorectal cancer (CRC) harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation; and dose escalation of ERAS-007 administered in combination with palbociclib in study participants with metastatic CRC harboring Kirsten rat sarcoma (KRAS) or neuroblastoma rat sarcoma (NRAS) mutations and metastatic pancreatic adenocarcinoma with (PDAC) KRAS mutation. Dose expansion will follow and will test ERAS-007 administered at the RD identified from each dose escalation arm in study participants with metastatic CRC.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years.
•Willing and able to give written informed consent.
•Have histologically or cytologically confirmed metastatic CRC harboring applicable mutation(s) (e.g., BRAF V600E; KRAS or NRAS mutations) or metastatic PDAC harboring KRAS mutation based on an analytically validated assay performed on tumor tissue in a certified testing laboratory.
•Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
•Adequate bone marrow and organ function.
•Have ECOG performance status of 0 or 1.
•Willing to comply with all protocol-required visits, assessments, and procedures.
•Able to swallow oral medication.

Exclusion Criteria

•Prior therapy with a RAS, MEK, or ERK inhibitor. Depending on which treatment arm the patient is assigned, other therapies could also be prohibitive.
•Anti-cancer therapy ≤ 21 days or 4 half-lives prior to first dose of study drug, whichever is shorter.
•Palliative radiation ≤ 7 days prior to first dose of study drug.
•Symptomatic brain metastasis or leptomeningeal disease.
•Gastrointestinal conditions that may affect absorption of oral medications
•Active infection requiring systemic therapy, or a known history of HIV infection, hepatitis B virus, or hepatitis C virus.
•History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first study drug dose.
•Active, clinically significant interstitial lung disease or pneumonitis.
•Impaired cardiovascular function or clinically significant cardiovascular disease.
•History of thromboembolic or cerebrovascular events ≤ 6 months prior to first dose.
+4 more criteria

Locations (14)

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

University of California Irvine College of Medicine

Orange, California, United States

UCSF Mount Zion Medical Ctr

San Francisco, California, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

Washington University (Siteman Cancer Center)

St Louis, Missouri, United States

Duke Cancer Institute

Durham, North Carolina, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

September 20, 2021

Primary Completion Date

August 1, 2025

Completion Date

December 1, 2025

Last Updated

February 11, 2025

Enrollment

102

ESTIMATED participants

Conditions

Metastatic Colorectal CancerMetastatic Pancreatic Ductal Adenocarcinoma

Interventions

ERAS-007

DRUG

Encorafenib

DRUG

Cetuximab

DRUG

Palbociclib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

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