Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FX-909 · 1 trial · 3 indications
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...
FX-909 is an investigational small molecule being studied for the treatment of advanced urothelial carcinoma. It is currently in Phase 1 clinical development, with an ongoing trial evaluating its safety and efficacy in patients with advanced solid malignancies, including advanced urothelial carcinoma.
FX-909 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's potential in oncology.
FX-909 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in an ongoing Phase 1 trial for advanced solid malignancies, including advanced urothelial carcinoma.
FX-909 is being evaluated in a Phase 1 clinical trial with the identifier NCT05929235. This open-label study is recruiting 120 participants in the United States and is investigating the drug in patients with advanced solid malignancies, including advanced urothelial carcinoma.
FX-909 is a distinct investigational small molecule developed by Merck & Company, Inc. No alternative names for FX-909 have been disclosed in the available clinical trial information, and it is being studied under its current designation.