Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05275478
Other study ID # TNG908-C101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 23, 2022
Est. completion date September 2025

Study information

Verified date May 2024
Source Tango Therapeutics, Inc.
Contact Tango Clinical Trials
Phone (857) 320-4899
Email clinicaltrials@tangotx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a Phase 1/2 multi-center, open label study in solid tumor patients (including glioblastoma) who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG908 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 6 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG908. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.


Recruitment information / eligibility

Status Recruiting
Enrollment 192
Est. completion date September 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally

Locations

Country Name City State
France Centre Léon Bérard Lyon
France EDOG Institut de Cancerologie de l'Ouest Saint-Herblain
France Institute Gustav Roussy Villejuif
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Chicago Illinois
United States NEXT Oncology Fairfax Virginia
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States University of California Los Angeles Los Angeles California
United States Sarah Cannon Tennessee Oncology Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Washington University Saint Louis Missouri
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Tango Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: To determine the MTD and dosing schedule of TNG908 28 days
Primary Phase 2: To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1 or modified RANO criteria 16 weeks
Secondary Phase 1: To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1or modified RANO criteria 16 weeks
Secondary Phase 1 and 2: To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs 28 days
Secondary Phase 1 and 2: Area under the plasma concentration versus time curve (AUC) 16 days
Secondary Phase 1 and 2: Time to achieve maximal plasma concentration (Tmax) 16 days
Secondary Phase 1 and 2: Maximum observed plasma concentration (Cmax) 16 days
Secondary Phase 1 and 2: Terminal elimination half-life (t1/2) 16 days
Secondary Phase 1 and 2: Apparent total plasma clearance when dosed orally (CL/F) 16 days
Secondary Phase 1 and 2: Apparent volume of distribution when dosed orally (Vz/F) 16 days
Secondary Phase 1 and 2: SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908 28 days
See also
  Status Clinical Trial Phase
Recruiting NCT04975958 - Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors Phase 1
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05378425 - A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab Phase 1
Recruiting NCT04260802 - A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers Phase 1/Phase 2
Not yet recruiting NCT05028478 - A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies Phase 1/Phase 2
Active, not recruiting NCT04250948 - Efficacy of Perioperative Chemotherapy Plus PD-1 Antibody in the Locally Advanced Gastric Cancer Phase 2
Recruiting NCT06184035 - A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer Phase 1/Phase 2
Completed NCT04914117 - A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours Phase 1
Recruiting NCT04614740 - The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04770688 - Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib Phase 1/Phase 2
Not yet recruiting NCT06415487 - ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) Phase 1
Not yet recruiting NCT06349408 - IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06028724 - A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Recruiting NCT05732831 - Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03284502 - HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT01390818 - Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05919264 - FOG-001 in Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04319757 - ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors Phase 1
Recruiting NCT03881488 - Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies Phase 1