Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Cholangiocarcinoma

Glioblastoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Bile Duct Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D

Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D

Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D

Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D

Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D

TNG908, a selective PRMT5 inhibitor, will be administered orally

TNG908

Tango Clinical Trials

Tim Cloughesy, MD

Nicholas Butowski, MD

Roger Stupp, MD

Ibiayi Dagogo-Jack, MD

Ugonma Chukwueke, MD

Angela Hirbe, MD, PhD

Mrinal Gounder, MD

David Spigel, MD

Jordi Rodon Ahnert, MD

Alex Spira, MD

Philippe Cassier, MD

Ludovic Doucet, MD

Capucine Baldini, MD

Ellen Hooper, MD

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.

Phase 1 dose escalation (sequential) followed by phase 2 dose expansion in 6 arms (parallel)

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

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

To determine the MTD and dosing schedule of TNG908

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

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

To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs

Area under the plasma concentration versus time curve (AUC)

Time to achieve maximal plasma concentration (Tmax)

Maximum observed plasma concentration (Cmax)

Apparent total plasma clearance when dosed orally (CL/F)

Apparent volume of distribution when dosed orally (Vz/F)

SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908

Spots Global Cancer Trial Database for tng908

Every month we try and update this database with for tng908 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tng908

Every month we try and update this database with for tng908 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tng908 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.