Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TH-302 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| [14C] TH-302 (Label 1) | EXPERIMENTAL | - |
| [14C] TH-302 (Label 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [14C] TH-302 (Label 1) | DRUG | \[14C\]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A. |
| [14C] TH-302 (Label 2) | DRUG | \[14C\]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A. |
| Unlabeled TH-302 | DRUG | Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m\^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death. |
Inclusion Criteria: * Male subject with pathologically or cytologically confirmed solid tumor which is locally advanced or metastatic, and either refractory to the standard therapy or for which no effective standard therapy is available * Subject has measurable and evaluable disease as RECIST versi...
| 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 |
TH-302 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development as a potential oncology therapy.
TH-302 is being developed by Merck & Company, Inc. (NYSE: MRK). The drug is currently in Phase 1 clinical trials for solid tumors.
TH-302 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
TH-302 has one completed Phase 1 trial, NCT02076230, titled "A Phase 1 TH-302 Mass Balance Trial." This trial enrolled 10 male participants aged 18 years and older with solid tumors and was conducted in Germany.
No, the completed Phase 1 trial of TH-302 (NCT02076230) was not randomized and was not double-blind. It was a controlled study that enrolled 10 participants with solid tumors.