Study on the Safety and Tolerability of TNG456 Alone and with Abemaciclib in Patients with Solid Tumors with MTAP Loss
Sponsor: Tango Therapeutics, Inc.
ClinicalTrials ID:NCT06810544
This clinical trial is testing a new drug, TNG456, alone and in combination with another drug, Abemaciclib, to see if it is safe and well-tolerated in patients with advanced solid tumors that have a specific genetic change called MTAP loss.
Patient Parameters
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Program Overview
This study is the first to test TNG456, a new drug taken by mouth, in humans. It is being tested alone and with another drug, Abemaciclib, in patients with advanced or spreading solid tumors that have a genetic change known as MTAP loss. The study has two parts: the first part will find the best dose of TNG456, and the second part will test this dose in specific types of tumors with MTAP loss. Up to 191 participants will be involved in this study.
Description
This clinical trial is a Phase 1/2 study conducted at multiple centers. It is open to patients with solid tumors that have a confirmed MTAP loss. In Phase 1, the study will determine the best dose of TNG456, which is taken by mouth, both alone and with Abemaciclib, in patients with these tumors. In Phase 2, the study will expand to include six groups of patients with specific types of tumors, using the best dose found in Phase 1. Participants who can tolerate the treatment may continue until their disease worsens.
Eligibility Criteria
Inclusion Criteria
- Have a tumor with a confirmed MTAP loss.
- Be 18 years or older.
- Have tried standard treatments without success, or no standard treatment is available, or the doctor believes standard treatment is not suitable.
- Be able to swallow tablets.
- Have good organ function based on local lab tests.
- Have a negative pregnancy test at screening if applicable.
- Have a performance status score of 0 to 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable disease based on standard criteria or a confirmed glioblastoma with evidence of disease progression.
Exclusion Criteria
- Be pregnant or breastfeeding.
- Have digestive issues that affect the absorption of oral medications.
- Have an active infection needing treatment.
- Have previously been treated with a PRMT5 or MAT2A inhibitor.
- For those receiving combination therapy, have previously been treated with a CDK4/6 inhibitor.
- Have significant heart disease.
- Have any other serious illness that could affect safety, study results, or compliance with the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NYU Langone Health | 10016 | New York | New York |
| NEXT Virginia | 22031 | Fairfax | Virginia |
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