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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
Adequate bone marrow and organ function
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

HERKULES-2 Trial Summary

This trial is testing the safety and effectiveness of two drugs, ERAS-007 and ERAS-601, when used in combination with other cancer therapies to treat advanced non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

HERKULES-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your bone marrow and organs are working properly.

HERKULES-2 Trial 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

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

HERKULES-2 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
~1010
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is ERAS-007 prescribed?

"ERAS-007 has been instrumental in treating previous platinum based therapy, therapeutic process and one prior systemic therapy."

Answered by AI

What tangible goals are being sought through this research?

"As part of the timespan from Day 1 to Day 22, this medical trial's primary outcome is a determination of Maximum Tolerated Dose (MTD). Other associated outcomes are Duration of Response (DOR), Plasma concentration (Cmax) and Time to achieve Cmax (Tmax), all defined according to RECIST version 1.1."

Answered by AI

In what quantity of sites is this investigation being conducted?

"11 medical facilities are currently enrolling patients, including the Dana Farber Research Institute in Boston, University of Colorado in Aurora and UC Los Angeles in Santa Monica. There are also numerous additional sites."

Answered by AI

What is the aggregate sum of participants engaged in this experiment?

"To move forward with the trial, 200 qualified individuals must be enrolled. Those wishing to take part can do so at Dana Farber Research Institute in Boston or University of Colorado in Aurora."

Answered by AI

Are there any available slots for participants in this research investigation?

"As per information found on clinicaltrials.gov, this research study is actively looking for participants with the original posting date of September 2nd 2021 and last update noted as August 4th 2022."

Answered by AI

Are participants of 85 years or older being accepted into this research project?

"All potential participants must meet the specified age requirement of 18 to 99. Moreover, there are 43 studies for minors under 18 and 2012 studies available specifically targeting seniors above 65 years old."

Answered by AI

What prerequisites must an individual meet to qualify for this research endeavor?

"This ongoing research study is currently recruiting 200 participants between the ages of 18 and 99 years-old who have been diagnosed with non-small cell lung carcinoma. Prospective candidates must be willing to provide written informed consent, demonstrate evidence of an EGFR mutation or KRAS G12C mutation, possess measurable disease based on RECIST v1.1 criteria, exhibit adequate bone marrow and organ function, hold a ECOG performance status score of 0 or 1, agree to attend all protocol visits and assessments as required by the trial regulations, and prove they can swallow oral medication."

Answered by AI

What further investigations have been carried out regarding ERAS-007?

"ERAS-007 is currently being investigated in 111 separate clinical trials, 18 of which are at the final stage. Despite most of these studies centred around Uniondale, New york, over 6000 locations worldwide are conducting research into this medication."

Answered by AI

Is this investigation innovative in its approach?

"Currently, 111 studies pertaining to ERAS-007 are being conducted around the world. These trials span 51 countries and 1175 cities, with AstraZeneca sponsoring 35 of them since 2013 - beginning with a Phase 1 & 2 trial involving 603 people."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
2021. "A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04959981.
~7 spots leftby Apr 2025
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