Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

  • To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 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 or ERAS-601 administered in combination with other cancer therapies. - To evaluate the antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies. - To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.

Official Title

A Phase 1b/2 Master Protocol of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Non-Small-Cell Lung Cancer

Details

This is a Phase 1b/2, open-label, multicenter master protocol evaluating safety, tolerability, and antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced NSCLC. The study will commence with the following dose escalation cohorts: ERAS-007 plus osimertinib in study participants with advanced NSCLC harboring epidermal growth factor receptor-sensitizing mutation(s) (EGFRm); ERAS-007 or ERAS-601 plus sotorasib in study participants with advanced NSCLC harboring Kirsten rat sarcoma G12C mutation (KRAS G12Cm). Dose expansion will follow and will evaluate ERAS-007 or ERAS-601 drug combinations administered at the RD identified from each respective dose escalation cohort in study participants with advanced EGFRm or KRAS G12Cm NSCLC.

Keywords

Advanced Non-squamous Non-small-cell Lung Cancer EGFR epidermal growth factor receptor mutation biomarker NSCLC Tagrisso osimertinib ERK MAPK sotorasib Lumakras KRAS G12C SHP2 PTPN11 molecular alterations Kirsten rat sarcoma Non-small cell lung cancer Lung neoplasms Thoracic neoplasms ERAS-601 ERAS-007 Carcinoma, Non-Small-Cell Lung

Eligibility

You can join if…

Open to people ages 18-99

  • Age ≥ 18 years.
  • Willing and able to give written informed consent.
  • Have histologically or cytologically confirmed NSCLC, with presence of EGFR mutation(s) sensitive to EGFR inhibitors, or KRAS G12C mutation.
  • 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 CAN'T join if...

  • Concurrent treatment with any systemic anticancer therapy for NSCLC, including any approved or investigational agent.
  • For participants with EGFRm NSCLC: prior therapy with a RAS, RAF, MEK, or ERK inhibitor.
  • For participants with KRAS G12Cm NSCLC: prior therapy with a SHP2, ERK, or KRAS G12C inhibitor (depending on which cohort is being considered for enrollment).
  • Palliative radiotherapy within 7 days of enrollment.
  • History of unacceptable toxicity to treatment with osimertinib or sotorasib.
  • 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 for toxicities not considered a safety risk (eg, alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy).
  • History of another malignancy ≤5 years prior to first dose, except for patients who are disease-free for >2 years after treatment with curative intent or who have carcinoma in situ.
  • Symptomatic and unstable brain metastases, or spinal cord compression, except for patients who have completed definitive therapy (surgery or radiotherapy), are not on steroids, and have a stable neurologic status for a least 2 weeks after completion of the definitive therapy and steroids.
  • History of or clinically active ILD, drug induced ILD, or radiation pneumonitis that required steroid treatment.
  • 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.
  • 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.
  • Pregnant or breastfeeding women.
  • Contraindication to osimertinib or sotorasib use as per local label.

Locations

  • UC Irvine, Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Erasca, Inc.
ID
NCT04959981
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated