← Back to searchRecruitingRecruiting
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
NCT06810544 · Tango Therapeutics, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed MTAP loss in their tumor. The Phase 1 portion is a dose escalation study of oral TNG456 administered as a single agent and in combination with oral abemaciclib in solid tumor patients with confirmed MTAP loss. In the Phase 2 expansion part of the study, 6 arms defined by confirmed tumor types will enroll in parallel at the RP2D(s) of TNG456 and in combination. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.
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 design
Enrollment target: 191 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-24
Estimated completion: 2027-09-30
Last updated: 2026-04-13
Interventions
Drug: TNG456Drug: abemaciclib
Primary outcomes
- • Phase 1 Maximum Tolerated Dose (21 days)
- • Phase 2 Anti-neoplastic Activity Single Agent (18 weeks)
- • Phase 2 Anti-neoplastic Activity Combination Treatment (18 weeks)
Sponsor
Tango Therapeutics, Inc. · industry
With: Eli Lilly and Company
Contacts & investigators
ContactTab Cooney, MD · contact · clinicaltrials@tangotx.com · (857) 320-4899
InvestigatorTab Cooney, MD · study_director, Tango Therapeutics, Inc.
All locations (15)
Mayo Clinic ScottsdaleRecruiting
Scottsdale, Arizona, United States
University of California, IrvineRecruiting
Irvine, California, United States
University of California Los AngelesRecruiting
Los Angeles, California, United States
University of California at San FranciscoRecruiting
San Francisco, California, United States
Sibley Memorial HospitalRecruiting
Washington D.C., District of Columbia, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo Clinic Cancer CenterRecruiting
Rochester, Minnesota, United States
NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Utah, Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States