Trial Title:
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
NCT ID:
NCT05732831
Condition:
Locally Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
MTAP deletion
PRMT5
cholangiocarcinoma
NSCLC
mesothelioma
MPNST
Tango
pancreatic
sarcoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1 dose escalation (sequential) followed by phase 2 dose expansion in 5 arms
(parallel)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TNG462
Description:
TNG462, a selective PRMT5 inhibitor, will be administered orally
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion in Mesothelioma
Arm group label:
Dose Expansion in NSCLC
Arm group label:
Dose Expansion in Pancreatic Ductal Adenocarcinoma
Arm group label:
Dose Expansion in Sarcoma
Arm group label:
Dose Expansion in Solid Tumors
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: ≥18 years-of-age at the time of signature of the main study ICF
2. Performance status: ECOG Performance Score of 0 to 1
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic,
and/or unresectable solid tumor
4. Prior standard therapy, as available
5. Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next-
generation sequencing or absence of MTAP protein in a tumor detected by IHC.
6. Adequate organ function/reserve per local labs
7. Adequate liver function per local labs
8. Adequate renal function per local labs
9. Negative serum pregnancy test result at screening
10. Written informed consent must be obtained according to local guidelines
Exclusion Criteria:
1. Known allergies, hypersensitivity, or intolerance to TNG462 or its excipients
2. Uncontrolled intercurrent illness that will limit compliance with the study
requirements
3. Active infection requiring systemic therapy
4. Currently participating in or has planned participation in a study of another
investigational agent or device
5. Impairment of GI function or disease that may significantly alter the absorption of
oral TNG462
6. Active prior or concurrent malignancy.
7. Central nervous system metastases associated with progressive neurological symptoms
8. Current active liver disease from any cause
9. Known to be HIV positive, unless all of the following criteria are met:
1. CD4+ count ≥300/μL
2. Undetectable viral load
3. Receiving highly active antiretroviral therapy
10. Clinically relevant cardiovascular disease
11. A female patient who is pregnant or lactating
12. Patient is unwilling or unable to comply with the scheduled visits, drug
administration plan, laboratory tests, biopsy, or other study procedures and study
restrictions
13. Patient has a prior or ongoing clinically significant illness, medical condition,
surgical history, physical finding, or laboratory abnormality that, in the
investigator's opinion, may affect the safety of the patient or impair the
assessment of study results
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Christopher Chen
Email:
Principal Investigator
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jose Lutzky, MD
Email:
Principal Investigator
Facility:
Name:
University Chicago Medicine
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Hedy Kindler, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Candace Haddox, MD
Email:
Principal Investigator
Facility:
Name:
Henry Ford Cancer Center
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Amy Weise, DO
Email:
Principal Investigator
Facility:
Name:
New York University Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Salman Punekar, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Spigel, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jordi Rodon Ahnert, MD
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ignacio Garrido-Iaguna, MD, PhD
Email:
Principal Investigator
Facility:
Name:
CHU de Brest
Address:
City:
Brest
Zip:
29200
Country:
France
Status:
Recruiting
Investigator:
Last name:
Jean-Philippe Metges, MD
Email:
Principal Investigator
Facility:
Name:
Centre Berard Leon
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Investigator:
Last name:
Philippe Cassier, MD
Email:
Principal Investigator
Facility:
Name:
Institute Gustav Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Investigator:
Last name:
Capucine Baldini, MD
Email:
Principal Investigator
Facility:
Name:
Vall d'Hebron Barcelona Hospital
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Irene Brana, MD
Email:
Principal Investigator
Facility:
Name:
Hospital HM Nou Delfos
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Tatiana Hernandez Guerrero, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Victor Moreno Garcia, MD
Email:
Principal Investigator
Facility:
Name:
Hospital de Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Emiliano Calvo Aller, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Javier Garcia-Corbacho, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alejandro Falcon, MD
Email:
Principal Investigator
Start date:
May 26, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Tango Therapeutics, Inc.
Agency class:
Industry
Source:
Tango Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732831
