Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Cholangiocarcinoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Bile Duct Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 to estimate the MTD

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D

Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D

Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D

Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D

TNG462, a selective PRMT5 inhibitor, will be administered orally

TNG462

Tango Clinical Trials

Christopher Chen

Jose Lutzky, MD

Candace Haddox, MD

Amy Weise, DO

Salman Punekar, MD

David Spigel, MD

Jordi Rodon Ahnert, MD

Ignacio Garrido-Iaguna, MD, PhD

Philippe Cassier, MD

Capucine Baldini, MD

Irene Brana, MD

Victor Moreno Garcia, MD

Emiliano Calvo Aller, 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, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 159 participants.

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG462 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 5 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG462. 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 5 arms (parallel)

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

To determine the maximum tolerated dose (MTD) of TNG462

To determine the dosing schedule of TNG462

To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 or mRECIST v1.1

To assess preliminary evidence of anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 or mRECIST v1.1

To describe the safety and tolerability profile of TNG462 by frequency and severity of AEs

Measure the area under the plasma concentration versus time curve (AUC)

Measure the time to achieve maximal plasma concentration (Tmax)

Measure the maximum observed plasma concentration (Cmax)

Determine the terminal elimination half-life (t1/2)

Determine the apparent total plasma clearance when dosed orally (CL/F)

Determine the apparent volume of distribution when dosed orally (Vz/F)

SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG462

Spots Global Cancer Trial Database for tng462

Every month we try and update this database with for tng462 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 tng462

Every month we try and update this database with for tng462 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 tng462 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.