TNG456 + Abemaciclib for Solid Tumors

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Tango Therapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Maeve Waldron-Lynch, MD

Principal Investigator

Tango Therapeutics, Inc.

Eligibility Criteria

This trial is for adults with advanced solid tumors, including lung cancer and glioblastoma, that have MTAP loss. Participants must be able to swallow tablets, have adequate organ function, measurable disease progression after standard care or no available standard therapy. Pregnant individuals can't join.

Inclusion Criteria

I can swallow pills.

Negative serum pregnancy test result at screening

I am fully active or can carry out light work.

Exclusion Criteria

Has a prior or ongoing clinically significant illness that may affect the safety of the patient, impair the assessment of study results or compliance with the protocol

I have been treated with a PRMT5 or MAT2A inhibitor before.

I am currently pregnant or breastfeeding.

Treatment Details

Interventions

• abemaciclib (CDK4/6 Inhibitor)
• TNG456 (PRMT5 Inhibitor)

Trial Overview The study tests TNG456 alone and combined with abemaciclib in patients whose tumors lack MTAP. It's a first-in-human study with two parts: dose escalation to find the safe amount and dose expansion to see effects on specific tumor types.

Participant Groups

Group I: Tumor Agnostic Single Agent Dose Expansion Experimental Treatment 1 Intervention

Patients with specific solid tumor types that have a confirmed MTAP loss will receive TNG456 at the identified RP2D(s)

Group II: Tumor Agnostic Combination Expansion Experimental Treatment 2 Interventions

Participants with specific tumor types with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib

Group III: Single Agent and Combination Dose Escalation Experimental Treatment 2 Interventions

Solid tumor participants with confirmed MTAP loss will receive escalating doses of TNG456 single agent and in combination with abemaciclib to estimate the MTD

Group IV: NSCLC Single Agent Dose Expansion Experimental Treatment 1 Intervention

NSCLC (squamous and non squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)

Group V: NSCLC Combination Expansion Experimental Treatment 2 Interventions

NSCLC (squamous and non-squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib

Group VI: GBM Single Agent Dose Expansion Experimental Treatment 1 Intervention

GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)

Group VII: GBM Combination Expansion Experimental Treatment 2 Interventions

GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib

Who Is Running the Clinical Trial?

Tango Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

740+