Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Recruiting · NCT05732831 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PembrolizumabTNG462
What this trial is about
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. The study is planned to treat up to 225 participants.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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 or to pembrolizumab in the combination treatment arms
- 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:
- CD4+ count ≥300/μL
- Undetectable viral load
- 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 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
Where it is running
26 locations listed across 11 US states.
- Stanford University - Palo Alto, California, United States
- Grand Valley Oncology - Grand Junction, Colorado, United States
- Florida Cancer Specialists & Research Institute - Lake Mary, Florida, United States
- Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- University Chicago Medicine - Chicago, Illinois, United States
- Carle Cancer Center - Urbana, Illinois, United States
- Midwestern Regional Medical Center, City of Hope Chicago - Zion, Illinois, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Cancer Center - Detroit, Michigan, United States
- New York University Langone Health - New York, New York, United States
- Sarah Cannon Tennessee Oncology - Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Huntsman Cancer Institute, University of Utah - Salt Lake City, Utah, United States
- Next Oncology Virginia - Fairfax, Virginia, United States
- Hospital HM Nou Delfos - Barcelona, Spain
- ICO l'Hospitalet - Hospital Duran i Reynals - Barcelona, Spain
- CHU de Brest - Brest, France
- Centre Berard Leon - Lyon, France
- Hospital Universitario Fundacion Jimenez Diaz - Madrid, Spain
- Hospital de Sanchinarro - Madrid, Spain
- Hospital Universitario Virgen de la Victoria - Málaga, Spain
- Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS - Saint-Herblain, France
- Hospital Universitario Virgen del Rocio - Seville, Spain
- Institute Gustav Roussy - Villejuif, France
- Vall d'Hebron Barcelona Hospital - Barcelona, Catalonia, Spain