Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tuvusertib [14C]Tuvusertib microtracer
Tuvusertib Tuvusertib microtracer · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Period 1: Mass Balance: Tuvusertib + [14C]Tuvusertib microtracer | EXPERIMENTAL | - |
| Period 1a: Absolute Bioavailability: Tuvusertib + [14C]Tuvusertib microdose bolus injection | EXPERIMENTAL | - |
| Period 2: Tuvusertib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tuvusertib [14C]Tuvusertib microtracer | DRUG | Participants will receive single oral dose of Tuvusertib containing a \[14C\] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions. |
| Tuvusertib | DRUG | Participants will also receive a single oral dose of Tuvusertib on Day 1 of Period 1 or Period 1a, and daily single oral dose of Tuvusertib for 2 weeks in 21 days cycle of Period 2. |
| Tuvusertib + [14C]Tuvusertib microdose bolus injection | DRUG | In Period 1a, participants will receive on Day 1 of Period 1 a single oral dose of tuvusertib and an intravenous (IV) (14C) tuvusertib microdose as bolus injection. |
Inclusion Criteria: * Are histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated * Eastern Cooperative Oncology Group Performance Statu...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Tuvusertib is an investigational small molecule developed by Merck KGaA for the treatment of solid tumors. It is being studied in a Phase 1 clinical trial and has not been approved by the FDA. The drug is also known as Tuvusertib [14C]Tuvusertib microtracer, reflecting a radiolabeled microtracer formulation used in clinical pharmacology studies.
Tuvusertib is being developed for the treatment of solid tumors. It is an investigational therapy currently in Phase 1 clinical development. The only completed trial to date enrolled 12 patients with solid tumors in Hungary, evaluating human mass balance and absolute bioavailability.
Tuvusertib is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is responsible for the clinical development of the drug, including the Phase 1 trial NCT06308263.
Tuvusertib is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Tuvusertib has been studied in one completed Phase 1 trial, NCT06308263, titled "Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)." The trial enrolled 12 patients with solid tumors in Hungary and is now completed.
Yes, Tuvusertib [14C]Tuvusertib microtracer is an alternative name for Tuvusertib. The bracketed notation indicates a carbon-14 radiolabeled microtracer version used in the human mass balance and absolute bioavailability study. Both names refer to the same investigational drug developed by Merck KGaA.