LY3410738 for Solid Tumors

Recruiting at 40 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Strong CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Active CNS metastases, Uncontrolled cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot participate if you are currently on certain strong CYP3A4 inhibitors or inducers, or P-gp inhibitors. It's best to discuss your specific medications with the trial team.

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1 dose escalation to determine the maximum tolerated dose of LY3410738

8-12 weeks

Dose Expansion

Phase 1 dose expansion to further evaluate safety and clinical activity in multiple cohorts

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3410738

Trial Overview 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.

Participant Groups

Group I: LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumab Experimental Treatment 4 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: LY3410738 Experimental Treatment 1 Intervention

Phase 1 dose escalation - Multiple doses of LY3410738

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology