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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05732831
Other study ID # TNG462-C101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 26, 2023
Est. completion date September 2026

Study information

Verified date May 2024
Source Tango Therapeutics, Inc.
Contact Tango Clinical Trials
Phone (857) 320-4899
Email clinicaltrials@tangotx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 159
Est. completion date September 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally

Locations

Country Name City State
France Centre Berard Leon Lyon
France Institute Gustav Roussy Villejuif
Spain Vall d'Hebron Barcelona Hospital Barcelona Catalonia
Spain Hospital de Sanchinarro Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
United States Dana Farber Cancer Institute Boston Massachusetts
United States Henry Ford Cancer Center Detroit Michigan
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Sylvester Comprehensive Cancer Center Miami Florida
United States Sarah Cannon Tennessee Oncology Nashville Tennessee
United States New York University Langone Health New York New York
United States Stanford University Palo Alto California
United States Huntsman Cancer Institute, University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Tango Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1 Maximum Tolerated Dose To determine the maximum tolerated dose (MTD) of TNG462 28 days
Primary Phase 1 Dosing Schedule To determine the dosing schedule of TNG462 28 days
Primary Phase 2 Anti-neoplastic Activity To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 or mRECIST v1.1 16 weeks
Secondary Phase 1 Anti-neoplastic Activity 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 16 weeks
Secondary Phase 1 and 2 Adverse Event Profile To describe the safety and tolerability profile of TNG462 by frequency and severity of AEs 28 days
Secondary Phase 1 and 2 Concentration versus Time Curve Measure the area under the plasma concentration versus time curve (AUC) 16 days
Secondary Phase 1 and 2 Time to Achieve Maximal Plasma Concentration Measure the time to achieve maximal plasma concentration (Tmax) 16 days
Secondary Phase 1 and 2 Maximum Observed Plasma Concentration Measure the maximum observed plasma concentration (Cmax) 16 days
Secondary Phase 1 and 2 Terminal Elimination Half-life Determine the terminal elimination half-life (t1/2) 16 days
Secondary Phase 1 and 2 Total Plasma Clearance Determine the apparent total plasma clearance when dosed orally (CL/F) 16 days
Secondary Phase 1 and 2 Volume of Distribution Determine the apparent volume of distribution when dosed orally (Vz/F) 16 days
Secondary Phase 1 and 2 SDMA Levels SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG462 28 days
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