NCT06810544 · Tango Therapeutics, Inc.
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
What this study is about
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 where both patients and doctors know the treatment given, gradually increasing doses and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss.
View original scientific 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.
Interventions
DRUG
TNG456
A selective PRMT5 inhibitor
DRUG
abemaciclib
A kinase inhibitor
Primary outcome measures
Phase 1 Maximum Tolerated Dose
Time frame: 21 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 Agent
Time frame: 18 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 Treatment
Time frame: 18 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Irvine, California
- Los Angeles, California
- San Francisco, California
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Chicago, Illinois
- Boston, Massachusetts
- Rochester, Minnesota
- New York, New York
- Columbus, Ohio
- Houston, Texas
And 2 more locations — see the full list below.
Collaborators
Eli Lilly and Company
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations