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Tisotumab Vedotin · 1 trial · 1 indication
To assess PK of tisotumab vedotin.PK parameters to be estimated will include area under the concentration-time curve (AUC).
To assess PK of tisotumab vedotin.PK parameters to be estimated will include maximum concentration (Cmax).
To assess PK of tisotumab vedotin.PK parameters to be estimated will include time to maximum concentration (Tmax).
To assess PK of tisotumab vedotin.PK parameters to be estimated will include apparent terminal half-life (t 1/2).
To assess PK of tisotumab vedotin.PK parameters to be estimated will include trough concentration (C trough).
| Name | Type | Description |
|---|---|---|
| Tisotumab Vedotin | DRUG | Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of solid tumors including cervical cancer. |
Inclusion Criteria: 1. Age ≥18 years. 2. Must sign an informed consent form (ICF) . 3. Must have recurrent or metastatic solid tumors and have failed on previous standard systemic therapy. 4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Has life expectancy of at le...
Tisotumab Vedotin is an investigational drug being studied for the treatment of solid malignancies, specifically in patients with metastatic or recurrent solid tumors. It is currently in Phase 1 clinical development, and a completed trial evaluated its pharmacokinetics in Chinese subjects with these conditions.
Tisotumab Vedotin is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical research on this drug for oncology indications, focusing on solid malignancies.
Tisotumab Vedotin is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities. It is still undergoing clinical evaluation for safety and pharmacokinetics.
Tisotumab Vedotin has one completed clinical trial, registered as NCT05866354. This Phase 1 study evaluated the pharmacokinetics of the drug in Chinese subjects with metastatic or recurrent solid malignancies. The trial enrolled 19 participants and was not randomized or blinded.
Tisotumab Vedotin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The available data shows a completed Phase 1 trial, but no approval status has been established, and the drug is still being studied for safety and efficacy.