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

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    170
  • sponsor
    Erasca, Inc.
Updated on 31 July 2021

Summary

  • To evaluate the safety and tolerability of ERAS-601.
    • To determine the ERAS-601 Maximum Tolerated Dose (MTD) and/or recommended dose (RD) as a monotherapy and in combination with a MEK inhibitor.
    • To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with a MEK inhibitor.

Description

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-601 SHP2 inhibitor as a monotherapy and in combination with a MEK inhibitor. The study will commence with dose escalation of ERAS-601 monotherapy, followed by dose escalation of ERAS-601 in combination with a MEK inhibitor. Once the monotherapy maximum tolerated dose (MTD) and/or recommended dose (RD) has been determined, then dose expansion of ERAS-601 monotherapy may commence. Dose expansion of ERAS-601 in combination with a MEK inhibitor may commence after the combination RD has been determined. Dose expansion will enroll participants with advanced or metastatic solid tumors harboring specific molecular alterations.

Details
Condition Advanced or Metastatic Solid Tumors
Treatment MEK inhibitor, ERAS-601
Clinical Study IdentifierNCT04670679
SponsorErasca, Inc.
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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
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

Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of Cycle 1, Day 1
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
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