Clinical Trials /

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

NCT04959981

Description:

- 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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of ERAS-007 in Patients With Advanced Non-Small-Cell Lung Cancer
  • Official Title: A Phase 1b/2, Open-Label, Multicenter Study of ERAS-007 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Non-Small-Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: ERAS-007-02
  • NCT ID: NCT04959981

Conditions

  • Advanced Non-squamous Non-small-cell Lung Cancer

Interventions

DrugSynonymsArms
ERAS-007Dose Escalation (Part 1): ERAS-007 QW plus osimertinib
osimertinibTagrissoDose Escalation (Part 1): ERAS-007 QW plus osimertinib

Purpose

- 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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation (Part 1): ERAS-007 QW plus osimertinibExperimentalERAS-007 will be orally administered QW in combination with osimertinib to study participants with advanced EGFRm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
  • ERAS-007
  • osimertinib
Dose Expansion (Part 2): ERAS-007 QW plus osimertinibExperimentalERAS-007 will be orally administered at the recommended dose (as determined from Part 1) in combination with osimertinib to study participants with advanced EGFRm NSCLC.
  • ERAS-007
  • osimertinib

Eligibility Criteria

        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.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities (DLT)
Time Frame:Study Day 1 up to Day 22
Safety Issue:
Description:Based on adverse events observed

Secondary Outcome Measures

Measure:Plasma concentration (Cmax)
Time Frame:Study Day 1 up to Day 22
Safety Issue:
Description:Maximum plasma concentration of ERAS-007 and other cancer therapies
Measure:Time to achieve Cmax (Tmax)
Time Frame:Study Day 1 up to Day 22
Safety Issue:
Description:Time to achieve maximum plasma concentration of ERAS-007 and other cancer therapies
Measure:Area under the curve
Time Frame:Study Day 1 up to Day 22
Safety Issue:
Description:Area under the plasma concentration-time curve of ERAS-007 and other cancer therapies
Measure:Half-life
Time Frame:Study Day 1 up to Day 22
Safety Issue:
Description:Half-life of ERAS-007 and other cancer therapies
Measure:Objective Response Rate (ORR)
Time Frame:Assessed up to 24 months from time of first dose
Safety Issue:
Description:Based on assessment of radiographic imaging per RECIST version 1.1
Measure:Duration of Response (DOR)
Time Frame:Assessed up to 24 months from time of first dose
Safety Issue:
Description:Based on assessment of radiographic imaging per RECIST version 1.1

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Erasca, Inc.

Trial Keywords

  • EGFR
  • epidermal growth factor receptor
  • mutation
  • biomarker
  • NSCLC
  • Tagrisso
  • osimertinib
  • ERK
  • MAPK

Last Updated

August 12, 2021