Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06810544 | Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss | PHASE1 | RECRUITING | 191 | — | — | Mar 24, 2025 | Sep 30, 2027 | Apr 13, 2026 | 15 | United States |
To determine the MTD, recommended dose(s) (RD), and dosing schedule of TNG456 monotherapy and in combination with abemaciclib
To assess the antitumor activity of TNG456 in patients with advanced or metastatic solid tumors with MTAP loss by RECIST or modified RANO criteria
To assess the antitumor activity of TNG456 in combination with abemaciclib in patients with advanced or metastatic tumors with MTAP loss by RECIST or modified RANO criteria
| Arm | Type | Description |
|---|---|---|
| Single Agent and Combination Dose Escalation | EXPERIMENTAL | Solid tumor participants with confirmed MTAP loss will receive escalating doses of TNG456 single agent and in combination with abemaciclib to estimate the MTD |
| NSCLC Single Agent Dose Expansion | EXPERIMENTAL | NSCLC (squamous and non squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) |
| GBM Single Agent Dose Expansion | EXPERIMENTAL | GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) |
| Tumor Agnostic Single Agent Dose Expansion | EXPERIMENTAL | Patients with specific solid tumor types that have a confirmed MTAP loss will receive TNG456 at the identified RP2D(s) |
| NSCLC Combination Expansion | EXPERIMENTAL | NSCLC (squamous and non-squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib |
| GBM Combination Expansion | EXPERIMENTAL | GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib |
| Tumor Agnostic Combination Expansion | EXPERIMENTAL | Participants with specific tumor types with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib |
| Name | Type | Description |
|---|---|---|
| TNG456 | DRUG | A selective PRMT5 inhibitor |
| abemaciclib | DRUG | A kinase inhibitor |
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...