RLY-4008 for Bile Duct Cancer

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Elevar Therapeutics

No Placebo Group

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.

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.

+13 more

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.

+3 more

Participant Groups

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).

4Treatment groups

Experimental Treatment

Group I: Part 4: RolloverExperimental Treatment1 Intervention

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

Group II: Part 3: ExtensionExperimental Treatment1 Intervention

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

Group III: Part 2: Dose ExpansionExperimental Treatment1 Intervention

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

Group IV: Part 1: Dose EscalationExperimental Treatment1 Intervention

Multiple doses of RLY-4008 for oral administration.