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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Colorectal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma

In brief

* 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.

Key facts

Study ID

NCT05039177

Run by

Erasca, Inc.

People needed

101

Starts

2021-09-20

Expected to finish

2026-01-26

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Major surgery within 28 days of enrollment, or anticipation of major surgery during study treatment.
• Known intolerance or contraindication to encorafenib, cetuximab, or palbociclib.
• Pregnant or breastfeeding women.
• Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study.

Where it is running

• 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
• Sarah Cannon Research Institute (Tennessee Oncology) — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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