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TNG456 and Abemaciclib for Solid Tumors with MTAP Loss

This study is testing TNG456, a drug that targets a protein called PRMT5, by itself and with abemaciclib, another drug that targets CDK4. It's for people with advanced solid tumors, including certain lung cancers and brain tumors, that have a specific change called MTAP loss. You can join if your cancer has progressed or if standard treatments aren't suitable. The study will look at the highest safe dose of TNG456 and how well it shrinks tumors, both alone and in combination with abemaciclib. Up to 191 people are expected to participate. The study status is currently unclear.

Study design
This is a Phase 1/2, multi-center, open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll up to 191 participants.
What's involved
Participants will take TNG456 by itself or in combination with abemaciclib. Treatment may continue until your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
The study measures anti-neoplastic activity (how well the treatment works against cancer) at 18 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06810544

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Tango Therapeutics, Inc.
~191 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:TNG456abemaciclib

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Maximum Tolerated Dose
Measured over 21 days
+2 more outcomes measured

Conditions

Non Small Cell Lung Cancer
Glioma Glioblastoma Multiforme
Glioma, Malignant
Solid Tumor
Non-Small Cell Adenocarcinoma
Lung Cancer
Brain Tumor

Explore related trials

GlioblastomaLung Non-Small Cell CarcinomaSolid NeoplasmMTAP Gene

Where it's being run

15 sites across 12 states
California3
New York2
Arizona1
District of Columbia1
Florida1
Illinois1
Massachusetts1
Minnesota1

Study leadership

  • Tab Cooney, MD · STUDY_DIRECTOR · Tango Therapeutics, Inc.

Who to contact

Tab Cooney, MD
[email protected]
(857) 320-4899
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

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

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

What this trial measures

  • Phase 1 Maximum Tolerated Dose21 days

    To determine the MTD, recommended dose(s) (RD), and dosing schedule of TNG456 monotherapy and in combination with abemaciclib

  • Phase 2 Anti-neoplastic Activity Single Agent18 weeks

    To assess the antitumor activity of TNG456 in patients with advanced or metastatic solid tumors with MTAP loss by RECIST or modified RANO criteria

  • Phase 2 Anti-neoplastic Activity Combination Treatment18 weeks

    To assess the antitumor activity of TNG456 in combination with abemaciclib in patients with advanced or metastatic tumors with MTAP loss by RECIST or modified RANO criteria