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ERAS-601 for Advanced Solid Cancer (FLAGSHP-1 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
Age ≥ 18 years
Have histologically or cytologically confirmed advanced or metastatic solid tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 24 months from time of first dose
Awards & highlights

FLAGSHP-1 Trial Summary

This trial is testing the safety and effectiveness of a new drug, ERAS-601, for treating advanced or metastatic solid tumors.

Who is the study for?
This trial is for adults (18+) with advanced or metastatic solid tumors who have no standard treatment options left, can't tolerate the usual treatments, or choose not to use them. Participants must be able to take oral medication and have a good performance status, meaning they're fully active or restricted in physically strenuous activity but can still carry out work of a light nature.Check my eligibility
What is being tested?
The study tests different doses of ERAS-601 alone and alongside cancer drugs Cetuximab and Pembrolizumab. It aims to find the highest dose patients can take without serious side effects (MTD), decide on a recommended dose (RD), understand how the body processes the drug (PK profile), and assess its effectiveness against tumors.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at injection sites, fatigue, skin issues like rash from Cetuximab, immune-related problems from Pembrolizumab such as inflammation in organs like lungs or intestines, flu-like symptoms, blood abnormalities.

FLAGSHP-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is advanced or has spread and confirmed by lab tests.
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I am fully active or can carry out light work.

FLAGSHP-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)
+5 more
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR)
Time to Response (TTR)
Other outcome measures
Pharmacodynamic assessment

FLAGSHP-1 Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumabExperimental Treatment2 Interventions
ERAS-601 will be administered in sequential ascending doses with pembrolizumab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or non small cell lung cancer (NSCLC).
Group II: Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximabExperimental Treatment2 Interventions
ERAS-601 will be administered in sequential ascending doses with cetuximab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC).
Group III: Dose Escalation (Part C): ERAS-601 monotherapyExperimental Treatment1 Intervention
ERAS-601 will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent.
Group IV: Dose Escalation (Part B): ERAS-601 monotherapyExperimental Treatment1 Intervention
ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.
Group V: Dose Escalation (Part A): ERAS-601 monotherapyExperimental Treatment1 Intervention
ERAS-601 monotherapy will be administered in sequential ascending doses to study 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-601
2021
Completed Phase 1
~30
Cetuximab
2011
Completed Phase 3
~2480
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor
6 Previous Clinical Trials
493 Total Patients Enrolled
Les Brail, PhDStudy DirectorClinical Development

Media Library

ERAS-601 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04670679 — Phase 1
Solid Tumors Research Study Groups: Dose Escalation (Part A): ERAS-601 monotherapy, Dose Escalation (Part B): ERAS-601 monotherapy, Dose Escalation (Part C): ERAS-601 monotherapy, Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximab, Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumab
Solid Tumors Clinical Trial 2023: ERAS-601 Highlights & Side Effects. Trial Name: NCT04670679 — Phase 1
ERAS-601 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04670679 — Phase 1

Frequently Asked Questions

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

Might I be eligible to join this medical study?

"This clinical trial needs to enrol 200 individuals aged 18-99 with a cancer diagnosis, that also meet the requirements of an ECOG PS score of 0 or 1 and are willing to participate in all necessary assessments."

Answered by AI

What is the aggregate quantity of participants in this research?

"Affirmative. The information on clinicaltrials.gov suggests that this medical study is currently seeking participants, and was first posted to the website on December 15th 2020, with its most recent update occurring November 16th 2022. 200 patients are needed from 8 different sites for enrolment in total."

Answered by AI

What are the safety implications for those using ERAS-601?

"ERAS-601 safety was judged to be a 1 on the scale of 1 to 3 due to the limited data available, indicating it is in Phase 1 of clinical trials."

Answered by AI

Are younger individuals aged 45 or under eligible to join this research project?

"This medical trial requires that participants are aged 18 to 99 years old. However, if you fall outside of this age range there are 303 studies for those under the age of consent and 2324 trials targeting individuals over 65."

Answered by AI

In how many venues is this research endeavor being conducted?

"The study is active in 8 locations, such as the Comprehensive Cancer Center of Nevada (Henderson), Sarah Cannon Research Institute (Tennessee Oncology; Nashville) and The University of Texas MD Anderson Cancer Centre (Houston). Several other facilities are also included."

Answered by AI

Are there any additional reports on the use of ERAS-601?

"Currently, 121 underway studies have been conducted on ERAS-601 with 30 trials in the Phase 3 stage. Most of these are happening out of Dresden, Arizona; however, there are 5333 other locations running their own research into ERAS-601."

Answered by AI

What purpose is ERAS-601 typically employed for?

"ERAS-601 is applied to manage pharmacotherapy, as well as regionally advanced squamous cell carcinoma of the head and neck (hnscc), metastatic squamous cell carcinoma of the head and neck, and general squamous cell carcinoma."

Answered by AI

Are there any vacancies for participation in this trial?

"Clinicaltrials.gov has confirmed that this clinical trial is actively looking for participants, with the initial post being made on December 15th 2020 and most recent edit occurring on November 16th 2022."

Answered by AI
~5 spots leftby May 2024