Tests TNG456, alone or with abemaciclib, in solid tumors with MTAP loss
Tests a pill, TNG456, alone or with abemaciclib, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
Key facts
- Where
- Boston, Chicago, Columbus, Fairfax, Houston, Irvine, Jacksonville, Los Angeles, New York, Rochester, Salt Lake City, San Francisco, Scottsdale, and Washington D.C., United StatesSee the 15 sites
- Phase
- Phase 1/2
Where in United States
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
- NEXT VirginiaFairfax, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- Mayo Clinic- JacksonvilleJacksonville, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- Mayo Clinic Cancer CenterRochester, United StatesTaking people
- University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
- University of California at San FranciscoSan Francisco, United StatesTaking people
- Mayo Clinic ScottsdaleScottsdale, United StatesTaking people
- Sibley Memorial HospitalWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tango Therapeutics, Inc.
- Trial code
- NCT06810544
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
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.
Inclusion: 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: 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; 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; Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s); Has an active infection requiring systemic therapy; Clinically relevant cardiovascular disease; A female patient is who is pregnant or breastfeeding.