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Tyrosine Kinase Inhibitor
RLY-4008 for Bile Duct Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Relay Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately every 2 weeks in cycle 1 (4-week cycle) and every other cycle (4-week cycles) from cycle 3, approximately 24 months
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced bile duct cancer or other solid tumors that have specific genetic changes in FGFR2. They should be able to perform daily activities with little help (ECOG 0-1) and may have had previous treatments, but not a drug targeting FGFR2. People can't join if they have active infections like HIV/HBV/HCV, serious heart issues, eye problems from similar drugs, poor organ function, or certain electrical heart disturbances.Check my eligibility
What is being tested?
RLY-4008 is being tested in patients with intrahepatic cholangiocarcinoma (ICC) and other solid tumors that haven't responded well to standard treatments. The study has three parts: finding the right dose of RLY-4008 (dose escalation), seeing how well it works at this dose (dose expansion), and long-term follow-up (extension).See study design
What are the potential side effects?
While the exact side effects of RLY-4008 are still being studied as it's a new drug, potential risks could include reactions related to liver function since it targets bile duct cancer. Other common side effects might involve digestive issues, fatigue, skin reactions or increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately every 2 weeks in cycle 1 (4-week cycle) and every other cycle (4-week cycles) from cycle 3, approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately every 2 weeks in cycle 1 (4-week cycle) and every other cycle (4-week cycles) from cycle 3, approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-4008
Part 1: Number of patients with adverse events and serious adverse events
Part 2 and Part 3: Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1
Secondary outcome measures
Part 1, Part 2, and Part 3: Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1
Part 1: Disease Control Rate (DCR) as assessed by Investigator per RECIST v1.1
Part 1: Duration of Response (DOR) assessed by Investigator per RECIST v1.1
+17 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: ExtensionExperimental Treatment1 Intervention
Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.
Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.
Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention
Multiple doses of RLY-4008 for oral administration.
Find a Location
Who is running the clinical trial?
Relay Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
665 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Part 3: Extension
- Group 2: Part 1: Dose Escalation
- Group 3: Part 2: Dose Expansion
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been accepted into this clinical research project?
"The study necessitates 440 individuals who meet the eligibility criteria. Citizens of Chicago, Illinois and Rochester, Minnesota can join at University of Chicago Medical Center and Mayo Clinic respectively."
Answered by AI
Is this experiment actively searching for participants?
"As indicated by clinicaltrials.gov, recruitment for this medical trial is ongoing and began on September 2nd 2020. The latest version of the study was published on November 11th 2022."
Answered by AI
Are there various sites conducting this research in Canada?
"The University of Chicago Medical Center, Mayo Clinic in Rochester and Massachusettes General Hospital are just 3 of the 18 locations operating this clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Moffitt Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried 2 other chemotherapy and immunotherapy as well as radiation therapy and have had progression. I would love to see if I am eligible for your clinical trial to try to stop this deadly disease.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Does it require an overnight stay? Will my family be able to be with me? How long will the trial last? Are mutations required? How many people will be able to be in trial?
PatientReceived 1 prior treatment
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