A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
NCT ID: NCT04959981
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2021-09-02
2023-04-27
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
ERAS-007
Administered orally
Osimertinib
Administered orally
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.
ERAS-007
Administered orally
Sotorasib
Administered orally
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.
ERAS-601
Administered orally
Sotorasib
Administered orally
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.
ERAS-007
Administered orally
Osimertinib
Administered orally
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.
ERAS-007
Administered orally
Sotorasib
Administered orally
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.
ERAS-601
Administered orally
Sotorasib
Administered orally
Interventions
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ERAS-007
Administered orally
ERAS-601
Administered orally
Osimertinib
Administered orally
Sotorasib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Erasca, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce Antal
Role: STUDY_DIRECTOR
Senior Director, Clinical Development
Locations
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City of Hope
Duarte, California, United States
UC Irvine, Chao Family Comprehensive Cancer Center
Orange, California, United States
UC Los Angeles
Santa Monica, California, United States
University of Colorado
Aurora, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Research Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Hackensack University Medical Center (John Theurer Cancer Center)
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Countries
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Other Identifiers
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ERAS-007-02
Identifier Type: -
Identifier Source: org_study_id
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