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

Running, not enrolling · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

* 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.

Key facts

Study ID

NCT04670679

Run by

Erasca, Inc.

People needed

90

Starts

2020-12-15

Expected to finish

2026-06-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Sarah Cannon Research Institute (Florida Cancer Specialists) — Sarasota, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute (Tennessee Oncology) — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Linear Clinical Research — Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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