Safety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors

Study Name
	Safety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
	NCT05732831
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy
Study Center
Institution Name
	The University of Texas MD Anderson Cancer Center
Institution Address
	1515 Holcombe Blvd
City
	Houston
State
	Texas
Zip Code
	77030
Country
	United States
Study Contacts
Principal Investigator
	Jordi Rodon Ahnert
P.I. Phone
	(713) 792-5603
P.I. Email
	jrodon@mdanderson.org
Study Coordinator
	Emily Curran
Study Coordinator Phone
	(713) 745-3970
Study Coordinator Email
	ejcurran@mdanderson.org
List additional Study Coordinators (include phone number and email)
	Uyen Vu umvu@mdanderson.org 713-794-1254
OVERVIEW – in layman’s terms (150 words max)
	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.
Enrollment
	Up to 159 patients
Study Start Date
	05/26/2023
Estimated Completion Date
	05/31/2026
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Phase 1: To determine the maximum tolerated dose and dosing schedule of TNG462 Phase 2: To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1
Inclusion Criteria – Patients Must:
	Age: ≥18 years-of-age at the time of signature of the main study ICF Performance status: ECOG Performance Score of 0 to 1 Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor Prior standard therapy, as available 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 Adequate organ function/reserve per local labs Adequate liver function per local labs Adequate renal function per local labs Negative serum pregnancy test result at screening Written informed consent must be obtained according to local guidelines
Exclusion Criteria – Patients Must NOT:
	Known allergies, hypersensitivity, or intolerance to TNG462 or its excipients Uncontrolled intercurrent illness that will limit compliance with the study requirements Active infection requiring systemic therapy Currently participating in or has planned participation in a study of another investigational agent or device Impairment of GI function or disease that may significantly alter the absorption of oral TNG462 Active prior or concurrent malignancy Central nervous system metastases associated with progressive neurological symptoms Current active liver disease from any cause Known to be HIV positive, unless all of the following criteria are met: (a) CD4+ count ≥300/μL, (b) Undetectable viral load, (c) Receiving highly active antiretroviral therapy Clinically relevant cardiovascular disease A female patient who is pregnant or lactating Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions Patient has 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
Financial Assistance is available to participants for travel, lodging, etc.
	Yes