RLY-4008 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+13 More
RLY-4008 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat cancer. It will study how well the drug works, what side effects it may cause, and how it is tolerated by patients.

Eligible Conditions
  • Breast Cancer
  • Intrahepatic Cholangiocarcinoma
  • Cholangiocarcinoma
  • FGFR2 Amplification
  • FGFR2 protein, human
  • FGFR2 Gene Mutation
  • Other Solid Tumors, Adult
  • Solid Tumors, Adult
  • Endometrial Cancer
  • Malignant Neoplasm of Stomach
  • FGFR2 Gene Activation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

Week 2
Pharmacokinetic parameters including area under the plasma concentration versus time curve from time 0 to 24 hours postdose (AUC0-24)
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
Pharmacokinetic parameters including terminal elimination half-life (t1/2)
Month 24
Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)
Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)
Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23)
Month 36
Disease Control Rate (DCR) as assessed by RECIST v1.1
Duration of Response (DOR) as assessed by RECIST v1.1
Duration of Response (DOR) assessed per RECIST v1.1
Objective Response Rate (ORR) assessed per RECIST v1.1
Overall response rate (ORR) as assessed by RECIST v1.1
Month 24
Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-4008
Month 24
FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue
Month 24
Number of patients with adverse events and serious adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

3 Treatment Groups

Part 3: Extension
1 of 3
Part 1: Dose Escalation
1 of 3
Part 2: Dose Expansion
1 of 3
Experimental Treatment

440 Total Participants · 3 Treatment Groups

Primary Treatment: RLY-4008 · No Placebo Group · Phase 1 & 2

Part 3: Extension
Drug
Experimental Group · 1 Intervention: RLY-4008 · Intervention Types: Drug
Part 1: Dose Escalation
Drug
Experimental Group · 1 Intervention: RLY-4008 · Intervention Types: Drug
Part 2: Dose Expansion
Drug
Experimental Group · 1 Intervention: RLY-4008 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately every 2 weeks in cycle 1 (4-week cycle) and every other cycle (4-week cycles) from cycle 3, approximately 24 months

Who is running the clinical trial?

Relay Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Breast Cancer
190 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a solid tumor with a histologically or cytologically confirmed unresectable or metastatic disease that is documented by local testing of blood and/or tumor
You have previously been treated with an FGFR inhibitor.
You have a tumor with a FGFR2 mutation or amplification.
You have a non-CCA FGFR2 fusion.
You have a non-CCA FGFR2 amplification.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 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.