A Study of ERAS-007 in Patients With Advanced Non-Small-Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Mar 24, 2024
  • participants needed
    200
  • sponsor
    Erasca, Inc.
Updated on 24 September 2021

Summary

  • To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced non-small cell lung cancer (NSCLC).
    • To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with other cancer therapies.
    • To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies.
    • To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination.

Description

This is a Phase 1b/2, open-label, multicenter clinical study evaluating ERAS-007 in combination with other cancer therapies in study participants with advanced NSCLC. This study will serve as a platform study, allowing for evaluation of safety/tolerability and efficacy of ERAS-007 in combination with other cancer therapies. The study will initially commence with dose escalation of ERAS-007 administered once weekly (QW) in combination with osimertinib in study participants with advanced NSCLC harboring an epidermal growth factor receptor-sensitizing mutation (EGFRm). Dose expansion will follow and will test ERAS-007 administered at the RD identified from dose escalation, in combination with osimertinib in study participants with EGFRm NSCLC.

Details
Condition Advanced Non Squamous Non Small Cell Lung Cancer
Treatment Osimertinib, ERAS-007
Clinical Study IdentifierNCT04959981
SponsorErasca, Inc.
Last Modified on24 September 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 NSCLC harboring EGFR mutation(s) sensitive to EGFR inhibitors at initial diagnosis per local approved label
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Adequate bone marrow and organ function
Have ECOG performance status of 0 or 1
Willing to comply with all protocol-required visits, assessments, and procedures
Able to swallow oral medication

Exclusion Criteria

Concurrent treatment with any systemic anticancer therapy for NSCLC, including any approved or investigational agent
Prior therapy with a RAS, RAF, MEK, or ERK inhibitor
Prior cancer immunotherapy (CIT) (e.g., immune checkpoint inhibitors), unless the CIT was followed by a non-CIT containing regimen prior to study enrollment
Anticancer treatment within 21 days of enrollment, except for osimertinib which may be continued during the screening period
Palliative radiotherapy within 7 days of enrollment
History of unacceptable toxicity to treatment with osimertinib
Major surgery within the 28 days of enrollment
Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of enrollment, except alopecia and grade 2 neuropathy due to prior chemotherapy
Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study
Impaired cardiovascular function or clinically significant cardiovascular disease
History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
Pregnant or breastfeeding women
Contraindication to osimertinib use as per local label
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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