ERAS-601 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer+1 More
ERAS-601 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Cancer
  • Advanced or Metastatic Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 3 Secondary · Reporting Duration: Assessed up to 24 months from time of first dose

Month 24
Adverse Events
Duration of Response (DOR)
Objective Response Rate (ORR)
Pharmacodynamic assessment
Time to Response (TTR)
Day 29
Area under the curve
Dose Limiting Toxicities (DLT)
Half-life
Maximum tolerated dose (MTD)
Plasma concentration (Cmax)
Recommended dose (RD)
Time to achieve Cmax (Tmax)

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

Dose Escalation (Part C): ERAS-601 monotherapy
1 of 8
Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuxi...
1 of 8
Dose Escalation (Part B): ERAS-601 monotherapy
1 of 8
Dose Expansion (Part D): ERAS-601 in combination with cetuximab
1 of 8
Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembro...
1 of 8
Dose Expansion (Part C): ERAS-601 monotherapy
1 of 8
Dose Escalation (Part A): ERAS-601 monotherapy
1 of 8
Dose Escalation (Part B): ERAS-601 in combination with cetuximab
1 of 8

Experimental Treatment

200 Total Participants · 8 Treatment Groups

Primary Treatment: ERAS-601 · No Placebo Group · Phase 1

Dose Escalation (Part C): ERAS-601 monotherapy
Drug
Experimental Group · 1 Intervention: ERAS-601 · Intervention Types: Drug
Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximabExperimental Group · 2 Interventions: Cetuximab, ERAS-601 · Intervention Types: Drug, Drug
Dose Escalation (Part B): ERAS-601 monotherapy
Drug
Experimental Group · 1 Intervention: ERAS-601 · Intervention Types: Drug
Dose Expansion (Part D): ERAS-601 in combination with cetuximabExperimental Group · 2 Interventions: Cetuximab, ERAS-601 · Intervention Types: Drug, Drug
Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, ERAS-601 · Intervention Types: Drug, Drug
Dose Expansion (Part C): ERAS-601 monotherapy
Drug
Experimental Group · 1 Intervention: ERAS-601 · Intervention Types: Drug
Dose Escalation (Part A): ERAS-601 monotherapy
Drug
Experimental Group · 1 Intervention: ERAS-601 · Intervention Types: Drug
Dose Escalation (Part B): ERAS-601 in combination with cetuximabExperimental Group · 2 Interventions: Cetuximab, ERAS-601 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2580
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed up to 24 months from time of first dose

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You have adequate cardiovascular, hematological, liver, and renal function.
You are willing to comply with all protocol-required visits, assessments, and procedures.
You have a histologically or cytologically confirmed advanced or metastatic solid tumor.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.