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NCT06810544RecruitingPhase 1/2

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
191 (estimated)
First submitted
24 Jan 2025
Start date
24 Mar 2025
Primary completion date
31 Mar 2027
Lead sponsor
Tango Therapeutics, Inc.
NCT number
NCT06810544

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 191
  • From 24 Mar 2025 to the primary completion date, 31 Mar 2027
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • A female patient is who is pregnant or breastfeeding

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Northwestern Memorial Hospital
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ChicagoUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
NEXT Virginia
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FairfaxUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of California, Irvine
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IrvineUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
University of California, Los Angeles
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Los AngelesUnited StatesRecruiting
NYU Langone Health
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New YorkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Mayo Clinic Cancer Center
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RochesterUnited StatesRecruiting
University of Utah - Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
University of California at San Francisco
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San FranciscoUnited StatesRecruiting
Mayo Clinic Scottsdale
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ScottsdaleUnited StatesRecruiting
Sibley Memorial Hospital
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Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.