Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of TNG456, taken by mouth, alone and with abemaciclib. It is for adults with solid tumors that are advanced or have spread and have a confirmed change called MTAP loss. This is the first study of TNG456 in humans.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older when signing the study consent form.
- Have a tumor with confirmed MTAP loss.
- Have cancer that got worse or did not respond enough to standard treatment, or be unable to tolerate it. You may also qualify if no standard treatment exists or the study doctor says it is not suitable.
- Be able to swallow tablets.
- Have organs that work well enough, based on lab tests.
- Have a negative blood pregnancy test at screening.
- Be fully active or able to do light work (ECOG score 0–1). For glioblastoma, a brain cancer, be able to care for yourself (Karnofsky score of at least 70).
- Have cancer that can be measured under study rules, or confirmed IDH-wildtype glioblastoma with scans showing that it has grown or returned.
Who can't join
- Be pregnant or breastfeeding.
- Have stomach or bowel problems that may greatly affect how your body absorbs the study pills.
- Have an active infection that needs treatment that works throughout the body.
- Have had treatment with a drug called a PRMT5 inhibitor or MAT2A inhibitor.
- For combination treatment in the study’s expansion part, have had a drug called a CDK4/6 inhibitor.
- Have important heart or blood vessel disease.
- Have a past or current serious illness that could affect your safety, the study results, or your ability to follow study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (15)
AZ
- Mayo Clinic Scottsdale · Scottsdale, AZ 85259-5452Mitesh Borad, MD · Principal investigatorMore trials in Scottsdale
CA
- University of California, Irvine · Irvine, CA 92686Cathleen Park, MD · Principal investigatorMore trials in Irvine
- University of California Los Angeles · Los Angeles, CA 90995Timothy Cloughesy, MD · Principal investigatorMore trials in Los Angeles
- University of California at San Francisco · San Francisco, CA 94143-2202Nicolas Butowski, MD · Principal investigatorMore trials in San Francisco
DC
- Sibley Memorial Hospital · Washington D.C., DC 20016Solmaz Sahebjam, MD · Principal investigatorMore trials in Washington D.C.
FL
- Mayo Clinic Jacksonville · Jacksonville, FL 32224Hani Babiker, MD · Principal investigatorMore trials in Jacksonville
IL
- Northwestern Memorial Hospital · Chicago, IL 60611-2908Ditte Primdahl, MD · Principal investigatorMore trials in Chicago
MA
- Dana Farber Cancer Institute · Boston, MA 02215Jia Luo, MD · Principal investigatorMore trials in Boston
MN
- Mayo Clinic Cancer Center · Rochester, MN 55905-0001Kaushal Parikh, MD · Principal investigatorMore trials in Rochester
NY
- NYU Langone Health · New York, NY 10016Salman Punekar, MD · Principal investigatorMore trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 11065Lauren Schaff, MD · Principal investigatorMore trials in New York
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Dwight Owen, MD · Principal investigatorMore trials in Columbus
TX
- MD Anderson Cancer Center · Houston, TX 77030Jordi Rodon, MD · Principal investigatorMore trials in Houston
UT
- University of Utah, Huntsman Cancer Institute · Salt Lake City, UT 84112-5500Howard Coleman, MD · Principal investigatorMore trials in Salt Lake City
VA
- NEXT Virginia · Fairfax, VA 22031Alexander Spira, MD, PhD · Principal investigatorMore trials in Fairfax