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ACTIVE NOT RECRUITING
NCT04670679
PHASE1

A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

Sponsor: Erasca, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

ERAS-601

Administered orally

DRUG

Cetuximab

Administered via intravenous infusion

DRUG

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