Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Launched by TANGO THERAPEUTICS, INC. · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called TNG456, which is being tested alone and together with another medication called abemaciclib for patients with advanced solid tumors that have a specific change known as MTAP loss. The trial aims to determine how safe these treatments are and how well they can be tolerated by patients. It is open to adults aged 18 and older who have tumors that have not responded well to standard treatments or where standard treatments are not suitable. They must be able to swallow tablets and have certain health criteria met.

Participants in this study will receive TNG456 and may also receive abemaciclib, depending on their condition. The trial is divided into two parts: initially, it will explore different doses of the medications, followed by a phase where it expands to treat specific types of tumors with confirmed MTAP loss. The study aims to include up to 191 participants. If you or a loved one is considering joining, it’s important to know that participants will be closely monitored for safety and the effectiveness of the treatments throughout the study.

Gender

ALL

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