Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Breast Neoplasms

Pancreatic Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD

Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab

Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab

Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab

TNG260

Pembrolizumab, an anti-PD-1 antibody, administered intravenously

Tiffany Wang, MD

Jonathan Goldman, MD

Gerald Falchook, MD

Judy Wang, MD

Mark Awad, MD, PhD

Shiresh Gadgeel, MD

Salman Punekar, MD

David Spigel, MD

Ferdinandos Skoulidis, MD

Alex Spira, MD

The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.

The main question\[s\] it aims to answer are:

* the recommended dose for Phase 2
* to evaluate the safety and tolerability of the combination therapy
* to determine the pharmacokinetics of TNG260
* to evaluate the initial antineoplastic activity

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.

Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion)

Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors

To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab

To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1

Measure the plasma concentration versus time curve (AUC) of TNG260 alone and when administered in combination with pembrolizumab

To characterize the Tmax by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab

To characterize the Cmax by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab

To characterize the T1/2 by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab

To characterize the pre treatment and trough concentration levels of pembrolizumab when administered in combination with TNG260

To evaluate the safety and tolerability of TNG260 when administered as single agent and in combination with pembrolizumab by measuring the incidence, nature, and severity of AE and SAE graded according to CTCAE v5.0

Measure changes in levels of histone acetylation in blood and/or tumor tissue, on study treatment relative to pre-treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors	NCT05887492	Non Small Cell ... Solid Tumors, A... Endometrial Can... Pancreatic Canc... Cervical Cancer Breast Cancer Carcinoma of Un...	TNG260 Pembrolizumab	18 Years -	Tango Therapeutics, Inc.
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors	NCT05887492	Non Small Cell ... Solid Tumors, A... Endometrial Can... Pancreatic Canc... Cervical Cancer Breast Cancer Carcinoma of Un...	TNG260 Pembrolizumab	18 Years -	Tango Therapeutics, Inc.

Spots Global Cancer Trial Database for tng260

Every month we try and update this database with for tng260 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 tng260

Every month we try and update this database with for tng260 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 tng260 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.