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A Study of ERAS-007 in Patients With Advanced Non-Small-Cell Lung Cancer (HERKULES-2)

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ClinicalTrials.gov Identifier: NCT04959981
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Erasca, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Non-squamous Non-small-cell Lung Cancer Drug: ERAS-007 Drug: osimertinib Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Arm Intervention/treatment
Experimental: Dose Escalation (Part 1): ERAS-007 QW plus osimertinib
ERAS-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.
Drug: ERAS-007
ERAS-007 will be administered orally as specified in Arm description.

Drug: osimertinib
80 mg orally once daily
Other Name: Tagrisso

Experimental: Dose Expansion (Part 2): ERAS-007 QW plus osimertinib
ERAS-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.
Drug: ERAS-007
ERAS-007 will be administered orally as specified in Arm description.

Drug: osimertinib
80 mg orally once daily
Other Name: Tagrisso




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT) [ Time Frame: Study Day 1 up to Day 22 ]
    Based on adverse events observed

  2. Maximum Tolerated Dose (MTD) [ Time Frame: Study Day 1 up to Day 22 ]
    Based on adverse events observed

  3. Recommended Dose (RD) [ Time Frame: Study Day 1 up to Day 22 ]
    Based on adverse events observed

  4. Adverse Events [ Time Frame: Assessed up to 24 months from time of first dose ]
    Incidence and severity of treatment-emergent AEs and serious AEs


Secondary Outcome Measures :
  1. Plasma concentration (Cmax) [ Time Frame: Study Day 1 up to Day 22 ]
    Maximum plasma concentration of ERAS-007 and other cancer therapies

  2. Time to achieve Cmax (Tmax) [ Time Frame: Study Day 1 up to Day 22 ]
    Time to achieve maximum plasma concentration of ERAS-007 and other cancer therapies

  3. Area under the curve [ Time Frame: Study Day 1 up to Day 22 ]
    Area under the plasma concentration-time curve of ERAS-007 and other cancer therapies

  4. Half-life [ Time Frame: Study Day 1 up to Day 22 ]
    Half-life of ERAS-007 and other cancer therapies

  5. Objective Response Rate (ORR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per RECIST version 1.1

  6. Duration of Response (DOR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per RECIST version 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04959981


Contacts
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Contact: Erasca Clinical Team 18584656511 clinicaltrials@erasca.com

Locations
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United States, New Jersey
Hackensack University Medical Center (John Theurer Cancer Center) Recruiting
Hackensack, New Jersey, United States, 07601
United States, Tennessee
Sarah Cannon Research Institute (Tennessee Oncology) Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Erasca, Inc.
Investigators
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Study Director: Kimberly Komatsubara, M.D. Senior Medical Director
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Responsible Party: Erasca, Inc.
ClinicalTrials.gov Identifier: NCT04959981    
Other Study ID Numbers: ERAS-007-02
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasca, Inc.:
EGFR
epidermal growth factor receptor
mutation
biomarker
NSCLC
Tagrisso
osimertinib
ERK
MAPK
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action