Informations générales (source: ClinicalTrials.gov)
A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Interventional
Phase 1/Phase 2
Tango Therapeutics, Inc. (Voir sur ClinicalTrials)
mars 2022
décembre 2025
24 juillet 2025
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. The study is
planned to treat up to 192 participants.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Capucine BALDINI | 25/06/2024 10:56:54 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| EDOG Institut de Cancerologie de l'Ouest - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Oncopole Claudius Regaud - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 or Karnofsky performance status
score ≥70.
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic,
and/or unresectable solid tumor or for GBM, have R/R disease.
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
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 or Karnofsky performance status
score ≥70.
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic,
and/or unresectable solid tumor or for GBM, have R/R disease.
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
1. Known allergies, hypersensitivity, or intolerance to TNG908 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 TNG908
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