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

Part of paid clinical trials in Duarte, California.

Sponsor
Erasca, Inc.
Study ID
NCT04959981
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Non-squamous Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ERAS-007 — DRUG
    Administered orally
  • ERAS-601 — DRUG
    Administered orally
  • Osimertinib — DRUG
    Administered orally
  • Sotorasib — DRUG
    Administered orally

Study Details

* 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.

Key Dates

Start date
Sep 2, 2021
Status verified
Jul 2023
Primary completion
Apr 27, 2023
Completion
Apr 27, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Part 1): ERAS-007 plus osimertinib
    ERAS-007 will be orally administered in combination with osimertinib to study participants with EGFRm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
  • Experimental: Dose Escalation (Part 2): ERAS-007 plus sotorasib
    ERAS-007 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
  • Experimental: Dose Escalation (Part 3): ERAS-601 plus sotorasib
    ERAS-601 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
  • Experimental: Dose Expansion (Part 4): ERAS-007 plus osimertinib
    ERAS-007 will be orally administered at the recommended dose (as determined from Part 1) in combination with osimertinib to study participants with EGFRm NSCLC.
  • Experimental: Dose Expansion (Part 5): ERAS-007 plus sotorasib
    ERAS-007 will be orally administered at the recommended dose (as determined from Part 2) in combination with sotorasib to study participants with KRAS G12Cm NSCLC.
  • Experimental: Dose Expansion (Part 6): ERAS-601 plus sotorasib
    ERAS-601 will be orally administered at the recommended dose (as determined from Part 3) in combination with sotorasib to study participants with KRAS G12Cm NSCLC.

Primary Outcome Measure

Dose Limiting Toxicities (DLT) [ Time Frame: Study Day 1 up to Day 22 ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UC Irvine, Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UC Los AngelesSanta MonicaCalifornia90404-
University of ColoradoAuroraColorado80045-
Dana Farber Research InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Hackensack University Medical Center (John Theurer Cancer Center)HackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research Institute (Tennessee Oncology)NashvilleTennessee37203-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUC Irvine, Chao Family Comprehensive Cancer Center· Orange, CAUC Los Angeles· Santa Monica, CAUniversity of Colorado· Aurora, CODana Farber Research Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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