TNG456 + Abemaciclib for Solid Tumors
Trial Summary
What is the purpose of this trial?
This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.
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 team or your doctor.
What data supports the effectiveness of the drug combination TNG456 and Abemaciclib for solid tumors?
The research highlights the use of precision medicine in oncology, where treatments are tailored based on the tumor's molecular profile, suggesting that targeted therapies like TNG456 and Abemaciclib could be more effective for specific patient groups. Additionally, the success of precision medicine trials in identifying effective drug combinations supports the potential of this approach.12345
What safety data exists for abemaciclib in humans?
What makes the drug TNG456 + Abemaciclib unique for treating solid tumors?
The combination of TNG456 and Abemaciclib is unique because Abemaciclib is a CDK4/6 inhibitor that has shown effectiveness in various cancers by blocking proteins that help cancer cells grow. This combination may offer a novel approach by potentially enhancing the immune response against tumors, which is different from standard treatments that typically target cancer cells directly.678911
Research Team
Maeve Waldron-Lynch, MD
Principal Investigator
Tango Therapeutics, Inc.
Eligibility Criteria
This trial is for adults with advanced solid tumors, including lung cancer and glioblastoma, that have MTAP loss. Participants must be able to swallow tablets, have adequate organ function, measurable disease progression after standard care or no available standard therapy. Pregnant individuals can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of TNG456 as a single agent and in combination with abemaciclib to estimate the maximum tolerated dose
Dose Expansion
Participants receive TNG456 at the recommended phase 2 dose (RP2D) as a single agent or in combination with abemaciclib, depending on tumor type
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- abemaciclib
- TNG456
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tango Therapeutics, Inc.
Lead Sponsor
Eli Lilly and Company
Industry 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