Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss (NCT06810544)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (8 items).
Location: Mayo Clinic Scottsdale — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Mayo Clinic Scottsdale — Scottsdale, Arizona
- University of California, Irvine — Irvine, California
- University of California Los Angeles — Los Angeles, California
- University of California at San Francisco — San Francisco, California
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Northwestern Memorial Hospital — Chicago, Illinois
- Dana Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic Cancer Center — Rochester, Minnesota
- NYU Langone Health — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- MD Anderson Cancer Center — Houston, Texas
- University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah
- NEXT Virginia — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (857) 320-4899
Email: clinicaltrials@tangotx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.