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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05887492 | Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors | PHASE1 | RECRUITING | 126 | — | — | Jun 12, 2023 | Jun 1, 2026 | Nov 18, 2025 | 13 | United States |
To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab
To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD |
| Dose Expansion in NSCLC with KRAS Mutation | EXPERIMENTAL | Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab |
| Dose Expansion in NSCLC with KRAS Wild type | EXPERIMENTAL | Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab |
| Dose Expansion in Advanced or Metastatic Solid Tumors | EXPERIMENTAL | Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab |
| Name | Type | Description |
|---|---|---|
| TNG260 | DRUG | CoREST inhibitor, administered orally |
| Pembrolizumab | DRUG | Pembrolizumab, an anti-PD-1 antibody, administered intravenously |
Inclusion Criteria: * Is ≥18 years of age at the time of signature of the main study ICF. * Has ECOG performance status of 0 or 1. * Has measurable disease based on RECIST v1.1. * All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytic...