LY3410738 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+40 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new oral drug called LY3410738 in patients with advanced solid tumors that have specific genetic mutations. The drug works by blocking abnormal enzymes to potentially stop or slow cancer growth.

Eligibility Criteria

Adults with advanced solid tumors that have specific mutations (IDH1 R132, IDH2 R140, or IDH2 R172) and are not responding to standard treatments. They should be in good physical condition (ECOG 0-1), able to swallow pills, and willing to use birth control. People who've had certain prior treatments or have active infections, uncontrolled diseases, brain metastases requiring steroids, or a history of severe immune-related side effects from other drugs can't join.

Inclusion Criteria

Measurable disease as determined by RECIST 1.1.

History of hypersensitivity to durvalumab or any excipient.

My cholangiocarcinoma has specific IDH1 or IDH2 mutations.

+29 more

Exclusion Criteria

I haven't taken any cancer drugs or investigational treatments in the last 2 to 4 weeks.

I have cholangiocarcinoma and have not undergone specific liver treatments in the last 4 weeks, nor do I have complications like ascites, encephalopathy, ongoing cholangitis, mixed cancer types, or a liver transplant history.

I have not had major surgery in the last 4 weeks.

+14 more

Participant Groups

The trial is testing LY3410738—an oral drug—on its own for safety and early signs of effectiveness against tumors with particular genetic changes. It's an open-label study where everyone knows what treatment they're getting. The trial includes patients with cancers like cholangiocarcinoma and glioma after some previous treatments failed.

2Treatment groups

Experimental Treatment

Group I: LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumabExperimental Treatment4 Interventions

Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of LY3410738 alone or in combination with gemcitabine plus cisplatin or in combination with durvalumab

Group II: LY3410738Experimental Treatment1 Intervention

Phase 1 dose escalation - Multiple doses of LY3410738