A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

• To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors.

• To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

• To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

• To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

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

Details

• Lead Sponsor: Erasca, Inc.
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Willing and able to give written informed consent

• Have histologically or cytologically confirmed advanced or metastatic solid tumor

• 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

• Able to swallow oral medication

• Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

• Adequate cardiovascular, hematological, liver, and renal function

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

Exclusion Criteria:

• Previous treatment with a SHP2 inhibitor

• Documented PTPN11 mutations

• Is 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-601

• Received prior palliative radiation within 7 days of Cycle 1, Day 1

• Have primary central nervous system (CNS) disease or known active CNS metastases and/or carcinomatous meningitis

• 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

• Active, clinically significant interstitial lung disease or pneumonitis

• History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment

• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO

• 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