Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Tisotumab vedotin will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial
National Cancer Center Hosptial East
Kashiwa-shi, Chiba, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
NHO Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Dose Escalation and Dose Expansion: Incidence of drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs) by CTCAE v5.0 [Safety]
Time frame: 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]
Time frame: Throughout the trial - until 90 days after last dose of tisotumab vedotin
Dose Escalation: maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of tisotumab vedotin
Time frame: 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: Maximum concentration (Cmax) after dosing
Time frame: 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))
Time frame: 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)
Time frame: Up to approximately 42 days after initial dose of tisotumab vedotin
Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Elimination half-life of the drug (T½)
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chūōku, Tokyo-To, Japan
Keio University Hospital
Shinjuku-ku, Tokyo-To, Japan
Time frame: 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)
Summarized by descriptive statistics by trial part and dose
Time frame: Throughout and at the end of trial (up to 90 days after last dose of tisotumab vedotin)
Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Objective Response Rate (ORR) (based on RECIST 1.1)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR)
Time frame: Up to approximately 6 months after the first dose of tisotumab vedotin
Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Duration of Response (DOR) (based on RECIST 1.1)
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.
Time frame: Up to approximately 6 months after the first dose of tisotumab vedotin
Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Time to Response (TTR) (based on RECIST 1.1)
TTR for a responder is defined as the time from the start of treatment with study drug to the first objective tumor response observed.
Time frame: Up to approximately 6 months after the first dose of tisotumab vedotin