Testing TNG456 and Abemaciclib in Patients with Solid Tumors Lacking MTAP
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
This study is testing a new drug called TNG456, alone and with another drug called abemaciclib, to see if it helps people with advanced solid tumors that have lost a specific gene called MTAP.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 191 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tango Therapeutics, Inc. Industry-sponsored |
| Locations | 15 sites (Scottsdale, Arizona and 14 other locations) |
| Trial ID | NCT06810544 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with solid tumors exhibiting confirmed MTAP loss who have not responded adequately to standard therapies.
Not a fit: Patients who do not have a confirmed MTAP loss in their tumors or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with solid tumors that have limited therapeutic alternatives due to MTAP loss.
How similar studies have performed: While this approach is novel in targeting MTAP loss, similar studies have shown promise in utilizing targeted therapies for specific genetic alterations in tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona and 14 other locations
- 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)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic Cancer Center — Rochester, Minnesota, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Tab Cooney, MD
- Email: clinicaltrials@tangotx.com
- Phone: (857) 320-4899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.