| 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 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 Address: jrodon@mdanderson.org
- Principal Investigator Phone: 713-792-5603
- Study Coordinator Name: Jing Yang
- Study Coordinator Phone: 713-745-9649
- Study Coordinator Email Address: jyang22@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 |
|
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| Location #3 |
|
Institution Name: Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02144 |
| Location #3 Study Contacts |
|
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| Location #4 |
|
Washington University School of Medicine, 660 S. Euclid Avenue, Campus Box 8076, St. Louis, MO 63110 |
| Location #4 Study Contacts |
|
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| Location #5 |
|
Centre Leon Berard, 28 rue Laennec, Lyon, Cedex 08, France, 69373 |
| Location #5 Study Contacts |
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| Location #6 |
|
Institute Gustav Roussy, 114, rue Edouard-Vaillant, 94805 Villejuif Cedex-France |
| Location #6 Study Contacts |
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| Location #7 |
|
Memorial Sloan Kettering Cancer Center
1275 York Avenue, New York, NY 10065 |
| Location #7 Study Contacts |
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| 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 192 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 or modified RANO.
|
| 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 or absence of MTAP protein in a tumor detected by IHC.
- 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
- 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
- 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
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