Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Launched by TANGO THERAPEUTICS, INC. · Feb 7, 2023

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ClinConnect Summary

This clinical trial is studying a new medication called TNG462, which is being tested for safety and tolerability in patients with advanced solid tumors that have a specific genetic change known as an MTAP deletion. The trial is designed for adults aged 18 and over who have been diagnosed with locally advanced or metastatic solid tumors and have already tried standard treatments. Participants will receive TNG462 in two parts: first, the researchers will gradually increase the dose to find the right amount that is both safe and effective, and then they will expand the study to include more patients with specific types of tumors that have this genetic change.

To be eligible for the trial, participants must have a confirmed diagnosis of cancer with the MTAP deletion, good overall health, and normal function of major organs like the liver and kidneys. Pregnant or breastfeeding women, those with certain other health issues, or individuals currently involved in other clinical trials will not be able to join. If you participate, you'll take the study drug by mouth and attend regular visits for monitoring and tests. This trial is an important step in understanding how TNG462 may help patients with these specific cancer types.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: ≥18 years-of-age at the time of signature of the main study ICF
• • 2. Performance status: ECOG Performance Score of 0 to 1
• • 3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
• • 4. Prior standard therapy, as available
• • 5. Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next- generation sequencing or absence of MTAP protein in a tumor detected by IHC.
• • 6. Adequate organ function/reserve per local labs
• • 7. Adequate liver function per local labs
• • 8. Adequate renal function per local labs
• • 9. Negative serum pregnancy test result at screening
• • 10. Written informed consent must be obtained according to local guidelines
• Exclusion Criteria:
• • 1. Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
• • 2. Uncontrolled intercurrent illness that will limit compliance with the study requirements
• • 3. Active infection requiring systemic therapy
• • 4. Currently participating in or has planned participation in a study of another investigational agent or device
• • 5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
• • 6. Active prior or concurrent malignancy.
• • 7. Central nervous system metastases associated with progressive neurological symptoms
• • 8. Current active liver disease from any cause
• 9. Known to be HIV positive, unless all of the following criteria are met:
• • 1. CD4+ count ≥300/μL
• • 2. Undetectable viral load
• • 3. Receiving highly active antiretroviral therapy
• • 10. Clinically relevant cardiovascular disease
• • 11. A female patient who is pregnant or lactating
• • 12. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
• • 13. Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results