drugset
drugset / Trial / NCT04866134

A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

NCT04866134 ↗

Phase 1/2 Active not recruiting 200 enrolled Erasca, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2021-05-07
Primary completion
2026-11-01
Completion
2027-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject ERAS-007 Unknown 250 mg Oral
Subject ERAS-601 Unknown — Oral

Indications

No indication recorded.