Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADH-1 · 5 trials · 21 indications
The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
| Arm | Type | Description |
|---|---|---|
| Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) | EXPERIMENTAL | Patients receive ADH-1 IV over 20-80 minutes on days 1, 4, 8, 11, 15, and 18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive maintenance therapy with cisplatin and gemcitabine hydrochloride. |
| Name | Type | Description |
|---|---|---|
| ADH -1 (Exherin™) | DRUG | - |
| ADH-1 | DRUG | Given IV |
| Cisplatin | DRUG | Given IV |
| Gemcitabine Hydrochloride | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| melphalan | DRUG | By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1 |
| ADH -1 and carboplatin | DRUG | - |
| ADH -1 and docetaxel | DRUG | - |
| ADH -1 and capecitabine | DRUG | - |
Inclusion Criteria: * Signed written informed consent * Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists * Histologically proven advanced and/or metastatic solid tumor of one of the following histo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
ADH-1 is an investigational small molecule being studied for the treatment of neoplasms, including ampulla of Vater adenocarcinoma. It is administered intravenously and is currently in Phase 1 clinical development. The drug is being evaluated as a single agent and in combination with other therapies for patients with solid tumors.
ADH-1 is being developed by Fennec Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FENC. The company is conducting clinical trials of ADH-1 in oncology indications, including studies in the United States, Canada, Italy, and Switzerland.
ADH-1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed four clinical trials, including Phase 1 and Phase 2 studies, but remains in early-stage development for the treatment of neoplasms.
ADH-1 has completed four clinical trials. These include a Phase 2 study of ADH-1 as a single agent (NCT00264433), a Phase 1 study in patients with solid tumors (NCT00265057), a Phase 1 study combining ADH-1 with carboplatin, docetaxel, or capecitabine (NCT00390676), and a Phase 1 study combining ADH-1 with melphalan via isolated limb infusion (NCT00421811).
ADH-1 is given intravenously. Clinical trials have evaluated it as a single agent and in combination with other cancer therapies, including carboplatin, docetaxel, capecitabine, and melphalan. The drug is being studied in adult patients with solid tumors and neoplasms.
ADH-1 is the primary name used in clinical trials for this investigational compound. No alternative names have been reported in the clinical trial records. The drug is being studied under the name ADH-1 by Fennec Pharmaceuticals Inc. in oncology indications.