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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 24 months from time of first dose

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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