Locally Advanced Solid Tumor Clinical Trial
Official title:
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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Tango Therapeutics, Inc. |
United States, France,
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 |
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