Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
Recruiting · NCT06810544 · Interventional (participants receive a specific treatment) · Lead sponsor: Tango Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
TNG456abemaciclib
What this trial is about
This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 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
- Has a tumor with a confirmed MTAP loss
- Is ≥18 years of age at the time of signature of the main study ICF
- Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate.
- Is able to swallow tablets
- Adequate Organ function/reserve per local labs
- Negative serum pregnancy test result at screening
- Has an ECOG performance status score of 0 to 1
- Has measurable disease based on RECIST v1.1 or a confirmed glioblastoma (IDH-wildtype) with radiographic evidence of disease progression or recurrence defined by RANO 2.0.
- Has an ECOG performance score of 0 to 1 or for GBM has a Karnofsky performance status score ≥70.
Exclusion criteria
- A female patient is who is pregnant or breastfeeding
- Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)
- Has an active infection requiring systemic therapy
- Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
- Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4/6 inhibitor
- Clinically relevant cardiovascular disease
- Has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol
Where it is running
15 locations listed across 12 US states.
- Mayo Clinic Scottsdale - Scottsdale, Arizona, United States
- University of California, Irvine - Irvine, California, United States
- University of California Los Angeles - Los Angeles, California, United States
- University of California at San Francisco - San Francisco, California, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Mayo Clinic Jacksonville - Jacksonville, Florida, United States
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Mayo Clinic Cancer Center - Rochester, Minnesota, United States
- NYU Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- University of Utah, Huntsman Cancer Institute - Salt Lake City, Utah, United States
- NEXT Virginia - Fairfax, Virginia, United States