A Study of ERAS-007 in Patients With Advanced Non-Small-Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2024-03-01
• 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 non-small cell lung cancer (NSCLC).

• 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: Osimertinib

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Willing and able to give written informed consent.

• Have histologically or cytologically confirmed advanced NSCLC harboring EGFR mutation(s) sensitive to EGFR inhibitors at initial diagnosis per local approved label.

• 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:

• Concurrent treatment with any systemic anticancer therapy for NSCLC, including any approved or investigational agent.

• Prior therapy with a RAS, RAF, MEK, or ERK inhibitor.

• Prior cancer immunotherapy (CIT) (e.g., immune checkpoint inhibitors), unless the CIT was followed by a non-CIT containing regimen prior to study enrollment

• Anticancer treatment within 21 days of enrollment, except for osimertinib which may be continued during the screening period.

• Palliative radiotherapy within 7 days of enrollment.

• History of unacceptable toxicity to treatment with osimertinib.

• Major surgery within the 28 days of enrollment.

• Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of enrollment, except alopecia and grade 2 neuropathy due to prior chemotherapy.

• 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.

• Impaired cardiovascular function or clinically significant cardiovascular disease.

• History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO.

• Pregnant or breastfeeding women.

• Contraindication to osimertinib use as per local label.