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MAPK Pathway Inhibitor

ERAS-007 for Non-Small Cell Lung Cancer (HERKULES-2 Trial)

Phase 1
Waitlist Available
Research Sponsored by Erasca, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 24 months from time of first dose
Awards & highlights

Summary

This trial is testing two new drugs, ERAS-007 and ERAS-601, in combination with other treatments for advanced lung cancer patients with specific genetic mutations. The goal is to see if these new drugs can enhance the effectiveness of existing treatments by targeting specific pathways in the cancer cells.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 24 months from time of first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months from time of first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Dose Limiting Toxicities (DLT)
Maximum Tolerated Dose (MTD)
+1 more
Secondary study objectives
Area under the curve
Duration of Response (DOR)
Half-life
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Expansion (Part 6): ERAS-601 plus sotorasibExperimental Treatment2 Interventions
ERAS-601 will be orally administered at the recommended dose (as determined from Part 3) in combination with sotorasib to study participants with KRAS G12Cm NSCLC.
Group II: Dose Expansion (Part 5): ERAS-007 plus sotorasibExperimental Treatment2 Interventions
ERAS-007 will be orally administered at the recommended dose (as determined from Part 2) in combination with sotorasib to study participants with KRAS G12Cm NSCLC.
Group III: Dose Expansion (Part 4): ERAS-007 plus osimertinibExperimental Treatment2 Interventions
ERAS-007 will be orally administered at the recommended dose (as determined from Part 1) in combination with osimertinib to study participants with EGFRm NSCLC.
Group IV: Dose Escalation (Part 3): ERAS-601 plus sotorasibExperimental Treatment2 Interventions
ERAS-601 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
Group V: Dose Escalation (Part 2): ERAS-007 plus sotorasibExperimental Treatment2 Interventions
ERAS-007 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
Group VI: Dose Escalation (Part 1): ERAS-007 plus osimertinibExperimental Treatment2 Interventions
ERAS-007 will be orally administered in combination with osimertinib to study participants with EGFRm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ERAS-007
2021
Completed Phase 1
~30
ERAS-601
2021
Completed Phase 1
~30
Osimertinib
2017
Completed Phase 4
~1100
Sotorasib
2021
Completed Phase 1
~370

Find a Location

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor
7 Previous Clinical Trials
1,139 Total Patients Enrolled
Kimberly Komatsubara, M.D.Study DirectorSenior Medical Director
1 Previous Clinical Trials
102 Total Patients Enrolled
Joyce AntalStudy DirectorSenior Director, Clinical Development
2 Previous Clinical Trials
572 Total Patients Enrolled
~6 spots leftby Sep 2025
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