A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
- Registration Number
- NCT03913741
- Lead Sponsor
- Genmab
- Brief Summary
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies
- Detailed Description
Part 1 of this trial will determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and the safety profile of tisotumab vedotin in subjects with solid malignancies. Part 2 of this trial will enroll subjects with cervical cancer to provide further data on the safety, tolerability, PK and anti-tumor activity
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental tisotumab vedotin tisotumab vedotin Open label, single arm trial where tisotumab vedotin will be administered
- Primary Outcome Measures
Name Time Method Dose Escalation: maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of tisotumab vedotin Up to 21 days after the first dose of tisotumab vedotin (each cycle is 21 days) Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Elimination half-life of the drug (T½) Up to approximately 42 days after initial dose of tisotumab vedotin Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Maximum concentration (Cmax) after dosing Up to approximately 42 days after initial dose of tisotumab vedotin Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC(0-t)) Up to approximately 42 days after initial dose of tisotumab vedotin Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin : Rate at which the drug is removed from the body (CL) Up to approximately 42 days after initial dose of tisotumab vedotin Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Time after dosing at which the maximum drug concentration was observed (Tmax) Up to approximately 42 days after initial dose of tisotumab vedotin Dose Escalation and Dose Expansion: Assess immunogenicity of tisotumab vedotin by measuring and assessing Anti-drug Antibody (ADA) Throughout and at the end of trial (up to 90 days after last dose of tisotumab vedotin) Summarized by descriptive statistics by trial part and dose
Dose Escalation and Dose Expansion: Incidence of drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs) by CTCAE v5.0 [Safety] Throughout the trial - until 90 days after last dose of tisotumab vedotin Dose Escalation and Dose Expansion: Incidence of Dose Limiting Toxicities (DLTs), AEs, SAEs, adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [Tolerability] Throughout the trial - until 90 days after last dose of tisotumab vedotin
- Secondary Outcome Measures
Name Time Method Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Time to Response (TTR) (based on RECIST 1.1) Up to approximately 6 months after the first dose of tisotumab vedotin TTR for a responder is defined as the time from the start of treatment with study drug to the first objective tumor response observed.
Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Objective Response Rate (ORR) (based on RECIST 1.1) Up to approximately 6 months after the first dose of tisotumab vedotin ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR)
Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Duration of Response (DOR) (based on RECIST 1.1) Up to approximately 6 months after the first dose of tisotumab vedotin The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Trial Locations
- Locations (8)
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo-To, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo-To, Japan
NHO Shikoku Cancer Center
🇯🇵Matsuyama-Shi, Ehime-Ken, Japan
National Cancer Center Hosptial East
🇯🇵Kashiwa-shi, Chiba-Ken, Japan
NHO Hokkaido Cancer Center
🇯🇵Sapporo-shi, Hokkaido, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka-Ken, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Saitama-Ken, Japan