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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 antibody-drug conjugate being developed by Zai Lab Limited for the treatment of solid malignancies. Zai Lab is studying it in Chinese subjects with metastatic or recurrent solid tumors. It is an investigational therapy and is in Phase 1 clinical development.
Tisotumab vedotin is being studied for use in metastatic or recurrent solid malignancies. The Phase 1 trial enrolled Chinese subjects with these advanced solid tumors. It is investigational and has not been established as a treatment outside of clinical research.
Zai Lab Limited, which trades under the ticker ZLAB, is the developer of tisotumab vedotin. The company is running clinical development of the antibody-drug conjugate in China for patients with metastatic or recurrent solid malignancies.
Tisotumab vedotin is in Phase 1 clinical development. The single listed trial, NCT05866354, is a completed Phase 1 pharmacokinetic study. Because it is still investigational, it has not been approved by the FDA for any indication based on this development program.
Tisotumab vedotin has been evaluated in one clinical trial, NCT05866354, titled a study to evaluate pharmacokinetics of tisotumab vedotin in Chinese subjects with metastatic or recurrent solid malignancies. This Phase 1 trial was completed, enrolled 19 participants, was uncontrolled, and was conducted in China.