MC# 21-07 - An Open-Label, Multi-Center Phase I/Ib Dose Escalation and Expansion Study of ERAS-601 SHP2 Inhibitor as a Monotherapy and in Combination with a MEK Inhibitor in Patients with Advanced or Metastatic Solid Tumors

  • Agent(s): ERAS-601
  • Disease Type(s): Solid Tumor
  • Phase(s): I
  • Drug Classification(s): Small Molecule, Targeted Therapy
  • Molecular Target(s): MAPK, SHP2

Mechanism of Action

ERAS-601 targets SHP2, a protein that plays an important role in modulating normal cell growth, and disrupts MAPK signaling, thereby shutting down the ability of cancer cells to grow and proliferate.

Purpose

In this study, the sponsor and investigators want to learn:

  • About the safety and tolerability of ERAS-601
  • Determine the recommended dose of ERAS-601 alone and in combination with MEK inhibitor
  • How proteins that indicate the status of your disease are affected with use of ERAS-601
  • If ERAS-601, alone or in combination with a MEK inhibitor, prevents or delays tumor growth or shrinks existing tumors
  • How much of ERAS-601 is absorbed into the blood and how fast it is removed
  • If research tests can be used in the future to predict who will benefit from ERAS-601
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

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT04670679

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Re: MC# 21-07