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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasca, Inc.
• Treatments: Cetuximab; Palbociclib

Criteria

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) 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 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.