Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Evofosfamide · 1 trial · 2 indications
A DLT was defined as any of the following toxicities at any dose level that occurred during the first cycle, and were considered to be related to the study drug by the Investigator or the Sponsor: - Grade 3 or Grade 4 non-hematological toxicity, except for Grade 3 or Grade 4 nausea, vomiting and diarrhea, - Grade 3 or higher skin reactions or mucosal toxicities, - Febrile neutropenia, - Grade 3 alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation lasting more than 7 days, - Grade 4 neutropenia lasting more than 5 days, - Grade 4 thrombocytopenia, - Grade 4 anemia, - Any non-preexisting Grade 2 or higher non-hematologic toxicity which, in the judgment of the Investigator and the Sponsor, was considered a DLT, - Any Grade 2 or higher non-hematologic toxicity that did not resolve to Grade 0 or Grade 1 toxicity by the start of the next cycle which, in the judgment of the Investigator and the Sponsor, was considered a DLT.
| Arm | Type | Description |
|---|---|---|
| Evofosfamide 240 mg | EXPERIMENTAL | - |
| Evofosfamide 340 mg | EXPERIMENTAL | - |
| Evofosfamide 480 mg | EXPERIMENTAL | - |
| Evofosfamide 340 mg + Gemcitabine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Evofosfamide | DRUG | Evofosfamide infusion intravenously at an escalated dose of 240, 340 or 480 milligram per square meter (mg/m\^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal. |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m\^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal. |
Inclusion Criteria: * At least 20 years of age * Signed written informed consent form * Histologically or cytologically confirmed advanced or metastatic solid tumor previously treated with one or more standard treatment regimen(s) or for which no effective therapy is available * Histologically or c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Evofosfamide is an investigational small molecule being studied for the treatment of solid tumors, including pancreatic cancer. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated in a completed Phase 1 trial in Japan.
Evofosfamide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with solid tumors.
Evofosfamide is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug remains investigational and has not received FDA approval.
Evofosfamide has been studied in a completed Phase 1 trial with the identifier NCT01833546. This trial, titled 'A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer,' enrolled 20 participants in Japan.
Yes, Evofosfamide is also known as TH-302. The completed Phase 1 trial NCT01833546 refers to the drug as TH-302, confirming that these names refer to the same investigational compound.