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A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
Sponsor: Erasca, Inc.
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
Conditions
Interventions
ERAS-007
ERAS-007 will be administered orally as specified in Arm description.
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