Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
NCT ID: NCT06810544
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
191 participants
INTERVENTIONAL
2025-03-24
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Single Agent and Combination Dose Escalation
Solid tumor participants with confirmed MTAP loss will receive escalating doses of TNG456 single agent and in combination with abemaciclib to estimate the MTD
TNG456
A selective PRMT5 inhibitor
abemaciclib
A kinase inhibitor
NSCLC Single Agent Dose Expansion
NSCLC (squamous and non squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
TNG456
A selective PRMT5 inhibitor
GBM Single Agent Dose Expansion
GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
TNG456
A selective PRMT5 inhibitor
Tumor Agnostic Single Agent Dose Expansion
Patients with specific solid tumor types that have a confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
TNG456
A selective PRMT5 inhibitor
NSCLC Combination Expansion
NSCLC (squamous and non-squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib
TNG456
A selective PRMT5 inhibitor
abemaciclib
A kinase inhibitor
GBM Combination Expansion
GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib
TNG456
A selective PRMT5 inhibitor
abemaciclib
A kinase inhibitor
Tumor Agnostic Combination Expansion
Participants with specific tumor types with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib
TNG456
A selective PRMT5 inhibitor
abemaciclib
A kinase inhibitor
Interventions
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TNG456
A selective PRMT5 inhibitor
abemaciclib
A kinase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Tango Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maeve Waldron-Lynch, MD
Role: STUDY_DIRECTOR
Tango Therapeutics, Inc.
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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TNG456-C101
Identifier Type: -
Identifier Source: org_study_id