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ERAS-007 + ERAS-601 for Advanced Cancer (HERKULES-1 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
Have ECOG performance status of 0 or 1 with an anticipated life expectancy of > 12 weeks
Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 24 months from time of first dose
Awards & highlights

HERKULES-1 Trial Summary

This trial is testing a new cancer drug, given either once a week or twice a week, to see if it is safe and effective.

Who is the study for?
Adults over 18 with advanced or metastatic solid tumors and specific molecular alterations, who have no standard treatment options left or can't tolerate them. They must be able to take oral meds, have recovered from previous treatments' side effects, and have a life expectancy of more than 12 weeks.Check my eligibility
What is being tested?
The trial is testing ERAS-007 alone with different dosing schedules and in combination with ERAS-601 for safety, tolerability, ideal dosage, pharmacokinetics (how the body processes the drugs), and effectiveness against various solid tumors.See study design
What are the potential side effects?
Specific side effects are not listed but generally include reactions related to drug tolerance levels such as digestive issues, fatigue, potential organ inflammation based on similar cancer therapies. The study aims to establish what these might be.

HERKULES-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and doctors expect me to live more than 12 weeks.
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My advanced cancer has a specific genetic change.
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I am 18 years old or older.

HERKULES-1 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
Area under the curve
Dose Limiting Toxicities (DLT)
+6 more
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR)
Time to Response (TTR)
Other outcome measures
Pharmacodynamic assessment

HERKULES-1 Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary)Experimental Treatment1 Intervention
Depending on data generated from Part A, ERAS-007 monotherapy may be administered at the BID-QW RD to participants with advanced or metastatic solid tumors that harbor specific molecular alterations.
Group II: Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosingExperimental Treatment1 Intervention
ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations.
Group III: Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601Experimental Treatment2 Interventions
Experimental: Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 ERAS-007 will be administered BID-QW in combination with ERAS-601 administered BID 3/1 to study participants with advanced or metastatic solid tumors that harbor specific molecular targets in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
Group IV: Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosingExperimental Treatment1 Intervention
ERAS-007 monotherapy will be administered BID-QW in sequential ascending doses to participants with advanced or metastatic solid tumors 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

Find a Location

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor
7 Previous Clinical Trials
963 Total Patients Enrolled
Wei Lin, M.D.Study DirectorChief Medical Officer
1 Previous Clinical Trials
102 Total Patients Enrolled

Media Library

ERAS-007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04866134 — Phase 1 & 2
Solid Tumors Research Study Groups: Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing, Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing, Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary), Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601
Solid Tumors Clinical Trial 2023: ERAS-007 Highlights & Side Effects. Trial Name: NCT04866134 — Phase 1 & 2
ERAS-007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04866134 — Phase 1 & 2

Frequently Asked Questions

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

Am I a valid candidate for participation in this medical experiment?

"In order to meet the selection criteria for this investigation, a patient must have an advanced or metastasized solid tumor and be between 18-99 years old. Altogether 200 individuals are needed."

Answered by AI

How many medical facilities are currently involved in the implementation of this experimental trial?

"The 5 locations hosting this clinical trial include Sarah Cannon Research Institute (Florida Cancer Specialists) in Sarasota, NEXT Oncology in San Antonio, and Sarah Cannon Research Institute (HealthONE) in Denver. Two other medical sites are also included."

Answered by AI

Are any new recruits being accepted for this clinical research?

"We can confirm that clinicaltrials.gov lists this medical trial as recruiting participants; it was initially posted on May 7th 2021 and last modified on July 6th 2021."

Answered by AI

What is the enrollment quota for this clinical trial?

"Affirmative. According to the information found on clinicaltrials.gov, this medical experiment is actively recruiting participants and has been since May 7th 2021 when it was originally posted. The trial seeks 200 patients from 5 different healthcare facilities, with their last update occurring July 6th 2021."

Answered by AI

Is geriatric enrollment permissible for this research endeavor?

"This clinical trial dictates that potential participants must be no younger than 18 and not exceed the age of 99."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
2021. "A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04866134.
~0 spots leftby May 2024
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