Testing TNG456 and Abemaciclib in Patients with Solid Tumors Lacking MTAP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of TNG456, a selective PRMT5 inhibitor, both alone and in combination with abemaciclib in patients with advanced solid tumors that have a confirmed loss of the MTAP gene. The study is divided into two phases: the first phase involves dose escalation of TNG456, while the second phase focuses on specific solid tumor types with MTAP loss at the recommended dose. Participants may continue treatment as long as they tolerate the drug and do not experience disease progression. The trial aims to enroll up to 191 participants across multiple centers.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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

Where it's running

• Mayo Clinic Scottsdale
  Scottsdale, Arizona, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• University of California at San Francisco
  San Francisco, California, United States Recruiting
• Sibley Memorial Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Adam Crystal, MD, PhD
• Email: clinicaltrials@tangotx.com
• Phone: (857) 320-4899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.