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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05929235 | A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma | PHASE1 | RECRUITING | 120 | — | — | Aug 24, 2023 | Jan 30, 2028 | Apr 20, 2026 | 12 | United States |
Incidence of dose-limiting toxicities (DLTs); Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | 3+3 design, 5 dose levels |
| Expansion Expansion | EXPERIMENTAL | Part B will proceed in a 2-stage design that will investigate 2 dose arms of FX-909 in Stage 1; with a single arm in Stage 2 envisioned. |
| FX-909 in Combination with Pembrolizumab | EXPERIMENTAL | Part 1A1 will be a dose-escalation study to investigate FX-909 in combination with Pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| FX-909 | DRUG | FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG. |
| Pembrolizumab (KEYTRUDA ®) | DRUG | Pembrolizumab is an immunotherapy checkpoint inhibitor. |
| KEYTRUDA ®( Pembrolizumab) | DRUG | Keytruda is an immunotherapy checkpoint inhibitor. |
Part A/B Inclusion Criteria: 1. Able to understand and willing to sign an informed consent. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 4. An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part...