Erasca, Inc is commencing the clinical trial of ERAS-007 for solid tumors

The scope of this study is:

  • To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW).
  • To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 monotherapy administered BID-QW.
  • To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy.
  • To determine the optimal dose and schedule of ERAS-007 monotherapy.
  • To evaluate antitumor activity of ERAS-007 in various solid tumors.

This is a Phase 1b/2, open-label, multicenter clinical study of ERAS-007 monotherapy administered either QW or BID-QW. The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study.

The dose escalation phase of this study will test ERAS-007 monotherapy administered BID-QW in participants with any solid tumor. In parallel, the dose expansion phase of this study will test ERAS-007 monotherapy administered at the RD of 250 mg QW in participants with advanced or metastatic solid tumors harboring specific molecular alterations. Once sufficient safety and PK data are available from the BID-QW dose escalation phase, the Sponsor will then determine the optimal dose and schedule of ERAS-007 administered as a monotherapy.

The researchers plan that May 1, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in November 1, 2024.

Among primary outcome measures are the Recommended dose (RD) and Based on adverse events observed.

The study will take place at the Sarah Cannon Research Institute (HealthONE), Denver, Colorado, United States; Sarah Cannon Research Institute (Florida Cancer Specialists), Sarasota, Florida, United States; Sarah Cannon Research Institute (Tennessee Oncology), Nashville, Tennessee, United States; The University of Texas MD Anderson Cancer Center, Houston, Texas, United States; NEXT Oncology, San Antonio, Texas, United States.

The inclusion and exclusion criteria may be found here: https://ichgcp.net/clinical-trials-registry/NCT04866134.

Clinical Research News

Upcoming Clinical Trials