Open Actively Recruiting

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
99 Years

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Join this Trial

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Study Stats
Protocol No.
22-000124
Category
Hematology-Oncology
Oncology
Contact
Tina Tieu
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04959981
For detailed technical eligibility, visit ClinicalTrials.gov.