NCT06810544

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 191 (estimated)
• Sponsor: Tango Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed MTAP loss in their tumor. The Phase 1 portion is a dose escalation study of oral TNG456 administered as a single agent and in combination with oral abemaciclib in solid tumor patients with confirmed MTAP loss. In the Phase 2 expansion part of the study, 6 arms defined by confirmed tumor types will enroll in parallel at the RP2D(s) of TNG456 and in combination. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Conditions

• Non Small Cell Lung Cancer
• Glioma Glioblastoma Multiforme
• Glioma, Malignant
• Solid Tumor
• Non-Small Cell Adenocarcinoma
• Lung Cancer
• Brain Tumor

Interventions

Type	Name	Description
DRUG	TNG456	A selective PRMT5 inhibitor
DRUG	abemaciclib	A kinase inhibitor

Timeline

• Start date: 2025-03-24
• Primary completion: 2027-03-31
• Completion: 2027-09-30
• First posted: 2025-02-05
• Last updated: 2026-04-13

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study