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A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
Sponsor: Erasca, Inc.
Summary
* To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors. * To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.
Official title: An Open-Label, Multi-Center Phase 1/1b Dose Escalation and Expansion Study of ERAS-601 SHP2 Inhibitor as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2020-12-15
Completion Date
2026-06
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
ERAS-601
Administered orally
Cetuximab
Administered via intravenous infusion
Pembrolizumab
Administered via intravenous infusion
Locations (14)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Sarah Cannon Research Institute (Florida Cancer Specialists)
Sarasota, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Perth, Western Australia, Australia