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ACTIVE NOT RECRUITING
NCT04866134
PHASE1/PHASE2

A Study of ERAS-007 as Monotherapy or in Combination With 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 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. * To evaluate the safety and tolerability of ERAS-007 (BID-QW) and ERAS-601 (twice daily for three weeks on and 1 week off (BID 3/1)) when administered in combination. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with ERAS-601. * To characterize the pharmacokinetic (PK) profile of ERAS-007 and ERAS-601 when administered in combination. * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors

Official title: A Phase 1b/2, Open-label, Multi-center Study of ERAS-007 (ERK Inhibitor) Administered as Monotherapy or in Combination With ERAS-601 (SHP2 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors (HERKULES-1)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2021-05-07

Completion Date

2025-11-01

Last Updated

2024-08-27

Healthy Volunteers

No

Interventions

DRUG

ERAS-007

ERAS-007 will be administered orally as specified in Arm description.

DRUG

ERAS-601

ERAS-601 will be administered orally as specified in Arm description.

Locations (5)

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

Mary Crowley Cancer Research

Dallas, Texas, United States

NEXT Oncology

San Antonio, Texas, United States