A Study of ERAS-007 in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasca, Inc.

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Willing and able to give written informed consent.

• Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable).

• There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy.

• Recovered from all toxicities associated with prior treatment to acceptable baseline status.

• Have ECOG performance status of 0 or 1 with an anticipated life expectancy of > 12 weeks.

• Willing to comply with all protocol-required visits, assessments, and procedures.

• Able to swallow tablets.

Exclusion Criteria:

• Currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-007.

• Received previous treatment with an ERK inhibitor.

• Received prior antineoplastic therapy within < 21 days or 5 half-lives, whichever is shorter.

• Received prior palliative radiation within 7 days of first dose of ERAS 007.

• Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity.

• Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption.

• Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.

• Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.