Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
NCT06810544 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 191
Last updated 2026-04-13
Summary
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.
Conditions
- Solid Tumor
- Non Small Cell Lung Cancer
- Glioma Glioblastoma Multiforme
- Glioma, Malignant
- Non-Small Cell Adenocarcinoma
- Lung Cancer
- Brain Tumor
Interventions
- DRUG
-
TNG456
A selective PRMT5 inhibitor
- DRUG
-
A kinase inhibitor
Sponsors & Collaborators
- collaborator INDUSTRY
-
Tango Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Tab Cooney, MD · Tango Therapeutics, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-24
- Primary Completion
- 2027-03-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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