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MAPK Pathway Inhibitor

Dose Escalation (Part 2): ERAS-601 plus gilteritinib for Acute Myeloid Leukemia (HERKULES-4 Trial)

Phase 1 & 2
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

HERKULES-4 Trial Summary

To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 or ERAS-601 administered in combination with other cancer therapies. To evaluate the preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.

Eligible Conditions
  • Acute Myeloid Leukemia

HERKULES-4 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
Antileukemic activity
Area under the curve
Duration of antileukemic activity
+3 more

HERKULES-4 Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion (Part 4): ERAS-601 plus gilteritinibExperimental Treatment2 Interventions
ERAS-601 will be administered at the recommended dose (as determined from Part 2) in combination with gilteritinib to study participants with R/R FLT3 mutated AML.
Group II: Dose Expansion (Part 3): ERAS-007 plus gilteritinibExperimental Treatment2 Interventions
ERAS-007 will be administered at the recommended dose (as determined from Part 1) in combination with gilteritinib to study participants with R/R FLT3 mutated AML.
Group III: Dose Escalation (Part 2): ERAS-601 plus gilteritinibExperimental Treatment2 Interventions
ERAS-601 will be administered in combination with gilteritinib to study participants with R/R FLT3 mutated AML in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
Group IV: Dose Escalation (Part 1): ERAS-007 plus gilteritinibExperimental Treatment2 Interventions
ERAS-007 will be administered in combination with gilteritinib to study participants with R/R FLT3 mutated AML 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-601
2021
Completed Phase 1
~30
ERAS-007
2021
Completed Phase 1
~30
Gilteritinib
2014
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor
7 Previous Clinical Trials
1,163 Total Patients Enrolled
Les Brail, Ph.D.Study DirectorMedical Monitor
Ida Enquist, Ph.D.Study DirectorMedical Monitor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
2022. "A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05279859.
~0 spots leftby Mar 2025
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