MC# 21-21 - A Phase Ib/II, Open-label, Multi-center Study of ERAS-007 in Patients with Advanced or Metastatic Solid Tumors

  • Agent(s): ERAS-007
  • Disease Type(s): Melanoma, Solid Tumor, Lung-NSCLC
  • Phase(s): I, II
  • Drug Classification(s): Targeted Therapy, Small Molecule
  • Molecular Target(s): ERK

Mechanism of Action

ERAS-007 targets ERK, 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-007
  • How much of ERAS-007 can be given with an acceptable level of side effects
  • The effects of ERAS-007 on certain proteins in your blood and tumor tissue
  • How much of ERAS-007 is absorbed into the blood and how fast it is removed
Inclusion Criteria
  1. Willing and able to give written informed consent
  2. Age ≥ 18 years
  3. Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable)
  4. 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
  5. Able to swallow tablets
  6. Have ECOG performance status of 0 or 1 with an anticipated life expectancy of > 12 weeks
  7. Recovered from all toxicities associated with prior treatment to acceptable baseline status
  8. Willing to comply with all protocol-required visits, assessments, and procedures
Exclusion Criteria
  1. Received previous treatment with an ERK inhibitor
  2. 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
  3. Patients with prior antineoplastic therapy within < 21 days or 5 half-lives, whichever is shorter
  4. Received prior palliative radiation within 7 days of first dose of ERAS-007
  5. Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity
  6. Current use or anticipated need for food or drugs that are known to be strong inhibitors of CYP3A4 and/or P-gp
  7. 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
  8. 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
  9. 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/NCT04866134

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Re: MC# 21-21