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Tisotumab vedotin

Antineoplastic Agents, Immunological

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.

Tisotumab Vedotin

Rutie Yin, Dr

Guiling Li, Dr

Bingzhong Zhang, Dr

Qing Wen, Dr

Meili Sun, Dr

Jianhua Shi, Dr

Dongqing Lv, Dr

Tienan Yi, Dr

The goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are:

* How is the PK of tisotumab vedotin?
* How is the immunogenicity of tisotumab vedotin?
* How is the safety and tolerability of tisotumab vedotin?
* How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population.

Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

This is an open-label, phase 1, PK trial of intravenous tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors who have failed on previous standard systemic therapy. The screening period will be up to 28 days, after which eligible subjects will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population.

Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

Blood samples for the assessment of tisotumab vedotin concentrations and antidrug antibody (ADA) will be drawn in accordance with the PK and ADA collection schedule. Three different PK analytes will be measured: 1) tisotumab vedotin (conjugated antibody only), 2) total antibody (ie, conjugated and unconjugated antibody), and 3) free MMAE. PK parameters to be estimated will include, but are not limited to, AUC, Cmax, time to maximum concentration (Tmax), apparent terminal half-life (t1/2), and trough concentration (Ctrough).

Safety and tolerability will be evaluated based on TEAEs, clinical safety assessments and clinical laboratory assessments. Ocular AEs are a known safety risk of tisotumab vedotin treatment. Therefore, the eye care plan will be implemented for all subjects enrolled in this trial.

Efficacy assessments will include confirmed ORR assessed by the investigator, primarily based on the enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans performed at protocol-specified time points. The RECIST v1.1 criteria will be used for response evaluation. After discontinuation of study treatment, tumor assessments may or may not be performed at the discretion of the investigator.

At the end of study (EOS), sponsor will ensure provision of continued tisotumab vedotin to subjects with clinical benefit defined as stable disease (SD) or better, until criteria of treatment discontinuation are met.

To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

An Open-Label, Phase 1 Trial to Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

When the study close， the IPD will share to other researchers per the requirement from Zailab.

Confirmed objective response rate (ORR) assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

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).

Anti-drug antibodies (ADAs) against tisotumab vedotin.

A TEAE is defined as a newly occurring or worsening AE from the first dose of study treatment to 30 days after the last dose of study treatment or initiation of new antitumor activities, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies	NCT05866354	Solid Malignanc...	Tisotumab Vedot...	18 Years -	Zai Lab (Hong Kong), Ltd.
To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies	NCT05866354	Solid Malignanc...	Tisotumab Vedot...	18 Years -	Zai Lab (Hong Kong), Ltd.

Spots Global Cancer Trial Database for metastatic or recurrent solid malignancies