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.
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
Drug | Synonyms | Arms |
---|
ERAS-007 | | Dose Escalation (Part 1): ERAS-007 QW plus osimertinib |
osimertinib | Tagrisso | Dose 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
Name | Type | Description | Interventions |
---|
Dose Escalation (Part 1): ERAS-007 QW plus osimertinib | Experimental | 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. | |
Dose Expansion (Part 2): ERAS-007 QW plus osimertinib | Experimental | 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. | |
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