Spots Global Cancer Trial Database for A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
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Trial Identification
Brief Title: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
Official Title: A Phase 1b Master Protocol of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Non-Small-Cell Lung Cancer
Study ID: NCT04959981
Study Description
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.
Detailed Description: This is a Phase 1b, 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Joyce Antal
Affiliation: Senior Director, Clinical Development
Role: STUDY_DIRECTOR
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