LY3410738 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and early effectiveness of a new treatment, LY3410738 (an experimental treatment), alone or combined with other drugs, for individuals with advanced solid tumors that have specific genetic changes (mutations in IDH1 or IDH2 genes). It includes conditions such as cholangiocarcinoma, chondrosarcoma, and glioma. Participants must have a confirmed IDH mutation and an advanced solid tumor that does not respond to standard treatments. This trial may suit those with these specific tumor types that no longer respond to other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LY3410738 has been tested in several studies for safety in people with certain advanced solid tumors. Previous patients generally tolerated the treatment well.
In these studies, some patients experienced side effects. The most common were fatigue, nausea, and low blood counts, which can make it harder for the body to fight infections. However, these side effects were usually mild or manageable.
As this is a Phase 1 trial, the main goal is to assess the safety of LY3410738 and determine the best dose. The treatment is still being tested to ensure its safety for humans.
Prospective participants should discuss any concerns with their doctor and understand the potential risks and benefits before joining this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about LY3410738 because it offers a novel approach to treating solid tumors. Unlike traditional chemotherapy drugs, LY3410738 is designed to target specific mutations in cancer cells, potentially leading to more effective and less toxic treatments. Additionally, in combination with gemcitabine and cisplatin or durvalumab, LY3410738 may enhance the overall treatment effectiveness by leveraging multiple mechanisms of action. This targeted approach could provide a significant advance over standard therapies, which often involve broader-acting treatments that can harm healthy cells along with cancerous ones.
What evidence suggests that LY3410738 could be an effective treatment for advanced solid tumors?
Research shows that LY3410738 may help treat tumors with specific genetic changes. Earlier studies found that it slowed tumor growth in certain types of bile duct cancer and brain tumors with these genetic changes. In this trial, participants may receive LY3410738 alone or with chemotherapy drugs like gemcitabine and cisplatin, which previously showed a success rate of 42.1%. Early trials also demonstrated that LY3410738 alone reduced tumor growth by more than 60% in lab tests. These results suggest that LY3410738 could be a promising treatment for patients with these specific genetic mutations in their tumors.23467
Who Is on the 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
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Phase 1 dose escalation to determine the maximum tolerated dose of LY3410738
Dose Expansion
Phase 1 dose expansion to further evaluate safety and clinical activity in multiple cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY3410738
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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