| ClinicalTrials.gov Identifier |
| NCT05732831 |
| Institution Name |
| The University of Texas MD Anderson Cancer Center |
| Institution Address (Street) |
| 1515 Holcombe Blvd |
| Institution City |
| Houston |
| Institution State |
| Texas |
| Institution ZIP Code |
| 77030 |
| Institution Country |
| United States |
| Additional Institutions |
- Sarah Cannon Research Institute
250 25th Avenue, Suite 307, Nashville, TN, United States, 37203
Study Contacts:
PI Name: David Spigel
PI Email Address: David.Spigel@sarahcannon.com
SC Name: Brook Petrasovits
SC Email Address: Brooke.Petrasovits@sarahcannon.com
- Dana Farber Cancer Institute
450 Brookline Avenue, Yakwey Building, Boston, MA, 02215
Study Contacts:
PI Name: Candace Haddox
PI Email Address: Candace_Haddox@DFCI.HARVARD.EDU
SC Name: Kyle Beaupre
SC Email Address: kyle_beaupre@dfci.harvard.edu
- University of Utah- Huntsman Cancer Institute
2000 Circle of Hope Drive, Salt Lake City, UT 84112
Study Contacts:
PI Name: Ignacio Garrido-Laguna
PI Email Address: ignacio.garrido-laguna@hci.utah.edu
SC Name: Heather Bratton
SC Email Address: heather.bratton@hci.utah.edu
- NYU Langone Health- Perlmutter Cancer Center
160 East 34th Street. New York, NY 10016
Study Contacts:
PI Name: Salman Punekar
PI Email Address: salman.punekar@nyulangone.org
SC Name: Nicholas Hatter
SC Email Address: nicholas.hatter@nyulangone.org
- University of Miami- Sylvester Comprehensive Cancer Center
1120 NW 14th Street, Miami, FL 33136
Study Contacts:
PI Name: Jose Lutzky
PI Email Address: jose.lutzky@med.miami.edu
SC Name: Claudia Ramirez
SC Email Address: cramirez@med.miami.edu
- Hospital Universitario Fundacion Jimenez Diaz
Avenida Reyes Catolicos 2, Madrid, Madrid, Spain 28040
Study Contacts:
PI Name: Victor Moreno Garcia
PI Email Address: victor.moreno@startmadrid.com
SC Name: Olga Ferrero
SC Email Address: olga.ferrero@startmadrid.com
- Hospital Universitatio HM Sanchinarro
Calle Ona 10, Madrid, Madrid, Spain, 28050
Study Contacts:
PI Name: Emiliano Calvo Aller
PI Email Address: emiliano.calvo@startmadrid.com
SC Name: Maria Garrido
SC Email Address: maria.garrido@startmadrid.com
- Vall d’Hebron Barcelona Hospital
Passeig Vall d’Hebron, 119-129, Barcelona, Barcelona, Spain, 08035
Study Contacts:
PI Name: Irene Braña Garcia
PI Email Address: ibrana@vhio.net
SC Name: Montse Pequera Juvany
SC Email Address: montsepequera@vhio.net
- Centre Leon Berard
28 rue Laennec, Lyon, Cedex 08, France, 69373
Study Contacts:
PI Name: Philippe Cassier
PI Email Address: philippe.cassier@lyon.unicancer.fr
SC Name: Anais Nuez
SC Email Address: Anais.NUEZ@lyon.unicancer.fr
- Institute Gustav Roussy, 114, rue Edouard-Vaillant, 94805 Villejuif Cedex-France
Study Contacts:
PI Name: Capucine Baldini
PI Email Address: capucine.baldini@gustaveroussy.fr
SC Name: Ngoc Anh Le
SC Email Address: ngocanh.le@gustaveroussy.fr
|
| Principal Investigator |
| Jordi Rodon Ahnert |
| Principal Investigator Phone |
| (713) 792-5603 |
| Principal Investigator Email |
| jrodon@mdanderson.org |
| Study Coordinator |
| Patricia Phillips |
| Study Coordinator Phone |
| (713) 745-9143 |
| Study Coordinator Email |
| PEPhillips@mdanderson.org |
| Additional Study Coordinators |
| Uyen Vu
umvu@mdanderson.org
713-794-1254 |
| Study Overview |
| 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 Information |
| Up to 159 patients |
| Study Start Date |
| 20230526 |
| Study End Date |
| 20260531 |
| Study Purpose |
- 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 |
- 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 |
- 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 Available |
| Yes |
