Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors

Study Name
Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
NCT05275478
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
NEXT Oncology
Institution Address
2829 Babcock Road
City
San Antonio
State
Texas
Zip Code
78229
Country
United States
List additional Institutions (include address, phone number, and website)
NEXT Oncology
8613 Lee Highway
Fairfax, VA 22031
Study Contacts
Principal Investigator
Tony Tolcher
P.I. Email
atolcher@nextoncology.com
List additional Principal Investigators (include phone number and email)
Alex Spira
aspira@nextoncology.com
Study Coordinator
Cynthia De Leon
Study Coordinator Email
cdeleon@nextoncology.com
List additional Study Coordinators (include phone number and email)
Carrie Friedman
carrie.friedman@usoncology.com
Location #1
The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, Texas, United States 77030
Location #1 Study Contacts
  • Principal Investigator Name: Jordi Rodon Ahnert
  • Principal Investigator Email Addressjrodon@mdanderson.org
  • Principal Investigator Phone: 713-792-5603
  • Study Coordinator Name: Uyen Vu
  • Study Coordinator Phone: 713-794-1254
  • Study Coordinator Email Addressumvu@mdanderson.org
Location #2
Sarah Cannon Research Institute – Tennessee Oncology, Institution Address: 250 25th Avenue, Suite 307, Nashville, TN, United States, 37203
Location #2 Study Contacts
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, TNG908, is a selective PRMT5 inhibitor administered orally.
Enrollment
Up to 170 patients.
Study Start Date
03/23/2022
Estimated Completion Date
04/30/2025
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 TNG908
  • Phase 2: To assess anti-neoplastic activity of TNG908 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 avaliable
  • Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next-generation sequencing
  • Adequate organ function/reserve per local labs
  • Adequate live function per local labs
  • Adequate renal function per local labs
  • Negative serum pregnancy test result at screening
  • Patient must be able to swallow tablets
  • Written informed consent must be obtained according to local guidelines
Exclusion Criteria – Patients Must NOT:
  • Known allergies, hypersensitivity, or intolerance to TNG908 or its excipients
  • Uncontrolled intercurrent illness that will limit compliance with the study requirements
  • Active infection requiring systemic therapy
  • Diagnosis of malignant glioma
  • Currently participating in or has planned participation in a stud of another investigational agent or device
  • Impairment of GI function or disease that may significantly alter the absorption of oral TNG908
  • 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 investigators opinion, may affect the safety of the patient or impair the assessment of study results