RLY-4008 for Bile Duct Cancer

Recruiting at 52 trial locations

Overseen By Relay Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Elevar Therapeutics

Must not be taking: FGFR inhibitors

Disqualifiers: Active infection, Cardiovascular disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

490 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called RLY-4008 in patients with hard-to-treat cancers that can't be removed by surgery or have spread. The drug works by blocking a protein that helps cancer cells grow.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

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.

Inclusion Criteria

Part 3 extension:

I have a solid tumor cancer that is not cholangiocarcinoma.

I have an FGFR2 amplification and haven't been treated with an FGFR inhibitor.

Exclusion Criteria

I have a heart condition that affects my heartbeat's timing.

I have a serious eye problem caused by FGFR inhibitor treatment.

I have a serious heart condition that is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Multiple doses of RLY-4008 for oral administration to determine the appropriate dose

8-12 weeks

Dose Expansion

Participants receive the oral dose of RLY-4008 as determined during Part 1 Dose Escalation

12-16 weeks

Extension

Participants continue to receive the oral dose of RLY-4008 as determined during Part 1 Dose Escalation

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• RLY-4008

Trial Overview 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).

Participant Groups

Group I: Part 4: Rollover Experimental Treatment 1 Intervention

Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.

Group II: Part 3: Extension Experimental Treatment 1 Intervention

Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.

Group III: Part 2: Dose Expansion Experimental Treatment 1 Intervention

Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.

Group IV: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Multiple doses of RLY-4008 for oral administration.

Who Is Running the Clinical Trial?

Elevar Therapeutics

Lead Sponsor

Trials

10

Recruited

1,200+

Relay Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,900+