Safety And Tolerability Of TNG908 In Patients With MTAP-deleted Solid Tumors

Study Overview

Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 participants.

This is a Phase 1/2 multi-center, open label study in solid tumor patients (including glioblastoma) who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG908 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 6 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG908. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Locally Advanced Solid Tumor

DRUG: TNG908

TNG908-C101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-02-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-04
First Submitted that Met QC Criteria 2022-03-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-06
First Posted (ACTUAL) 2022-03-11	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally
EXPERIMENTAL: Dose Expansion in NSCLC Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally
EXPERIMENTAL: Dose Expansion in Mesothelioma Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally
EXPERIMENTAL: Dose Expansion in Pancreatic Ductal Adenocarcinoma Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally
EXPERIMENTAL: Dose Expansion in Sarcoma Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally
EXPERIMENTAL: Dose Expansion in solid tumors Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally
EXPERIMENTAL: Dose Expansion in Glioblastoma Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D	DRUG: TNG908 TNG908, a selective PRMT5 inhibitor, will be administered orally

Primary Outcome Measures	Measure Description	Time Frame
Phase 1:	To determine the MTD and dosing schedule of TNG908	28 days
Phase 2:	To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1 or modified RANO criteria	16 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Phase 1:	To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1or modified RANO criteria	16 weeks
Phase 1 and 2:	To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs	28 days
Phase 1 and 2:	Area under the plasma concentration versus time curve (AUC)	16 days
Phase 1 and 2:	Time to achieve maximal plasma concentration (Tmax)	16 days
Phase 1 and 2:	Maximum observed plasma concentration (Cmax)	16 days
Phase 1 and 2:	Terminal elimination half-life (t1/2)	16 days
Phase 1 and 2:	Apparent total plasma clearance when dosed orally (CL/F)	16 days
Phase 1 and 2:	Apparent volume of distribution when dosed orally (Vz/F)	16 days
Phase 1 and 2:	SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908	28 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Maxim Pimkin, MD, PhD, Tango Therapeutics, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record