RECRUITING

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

Conditions

Non Small Cell Lung Cancer Glioma Glioblastoma Multiforme Glioma, Malignant Solid Tumor Non-Small Cell Adenocarcinoma Lung Cancer Brain Tumor MTAP PRMT5 inhibitor CDK 4/6 abemaciclib Tango

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-24

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06810544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Maeve Waldron-Lynch, MD

CONTACT

(857) 320-4899

clinicaltrials@tangotx.com

Principal Investigator

Maeve Waldron-Lynch, MD

STUDY_DIRECTOR

Tango Therapeutics, Inc.

Study Locations (Sites)

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Tango Therapeutics, Inc.

Maeve Waldron-Lynch, MD, STUDY_DIRECTOR, Tango Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2025-03-24

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

MTAP
PRMT5 inhibitor
CDK 4/6
abemaciclib
Tango

Additional Relevant MeSH Terms

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