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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Virginia
NEXT Virginia
RECRUITING
Fairfax
Contact Information
Primary
Maeve Waldron-Lynch, MD
clinicaltrials@tangotx.com
(857) 320-4899
Time Frame
Start Date:2025-03-24
Estimated Completion Date:2027-09-30
Participants
Target number of participants:191
Treatments
Experimental: 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
Experimental: NSCLC Single Agent Dose Expansion
NSCLC (squamous and non squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
Experimental: GBM Single Agent Dose Expansion
GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
Experimental: 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)
Experimental: NSCLC Combination Expansion
NSCLC (squamous and non-squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib
Experimental: GBM Combination Expansion
GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib