RLY-4008 for Breast Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Breast Cancer+13 More
RLY-4008 - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
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
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: DrugPart 1: Dose Escalation
Drug
Experimental Group · 1 Intervention: RLY-4008 · Intervention Types: DrugPart 2: Dose Expansion
Drug
Experimental Group · 1 Intervention: RLY-4008 · Intervention Types: DrugTrial 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 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.
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Conditions
Cancer Related
Treatments