- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913741
A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies (innovaTV 206)
June 17, 2022 updated by: Genmab
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba-Ken
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Kashiwa-shi, Chiba-Ken, Japan, 277-8577
- National Cancer Center Hosptial East
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Ehime-Ken
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Matsuyama-Shi, Ehime-Ken, Japan, 791-0280
- NHO Shikoku Cancer Center
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 003-0804
- Nho Hokkaido Cancer Center
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Kanagawa-Ken
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Yokohama-shi, Kanagawa-Ken, Japan, 241-8515
- Kanagawa cancer center
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Saitama-Ken
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Hidaka-shi, Saitama-Ken, Japan, 350-1298
- Saitama Medical University International Medical Center
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Shizuoka-Ken
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Sunto-gun, Shizuoka-Ken, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo-To
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Chuo-ku, Tokyo-To, Japan, 104-0045
- National Cancer Center Hospital
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Shinjuku-ku, Tokyo-To, Japan, 160-8582
- Keio University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (Main):
- PART 1 ONLY: Subjects with locally advanced or metastatic solid tumors, who have experienced disease progression while on standard therapy or are intolerant of, or not eligible for, standard therapy.
- PART 2 ONLY: Subjects with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
Patients must not have received more than 2 prior systemic treatment regimens for recurrent or metastatic cervical disease.
- Measurable disease according to RECIST v1.1
- Must be at least 20 years of age on the day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration
- Women of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration
- A man who is sexually active with a WOCBP and has not had a vasectomy must agree to use a barrier method of birth control (Part 1 only)
- Must provide signed informed consent before any trial-related activity is carried out.
Exclusion Criteria (Main):
- PART 2 ONLY: Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.
- Known past or current coagulation defects leading to an increased risk of bleeding.
- Ongoing major bleeding.
- Has an active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental tisotumab vedotin
Open label, single arm trial where tisotumab vedotin will be administered
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Throughout the trial - until 90 days after last dose of tisotumab vedotin
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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
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Throughout the trial - until 90 days after last dose of tisotumab vedotin
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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)
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Up to 21 days after the first dose of tisotumab vedotin (each cycle is 21 days)
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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
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Up to approximately 42 days after initial dose of tisotumab vedotin
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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
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Up to approximately 42 days after initial dose of tisotumab vedotin
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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
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Up to approximately 42 days after initial dose of tisotumab vedotin
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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
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Up to approximately 42 days after initial dose of tisotumab vedotin
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Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Time after dosing at which the maximum drug concentration was observed (Tmax)
Time Frame: Up to approximately 42 days after initial dose of tisotumab vedotin
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Up to approximately 42 days after initial dose of tisotumab vedotin
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Dose Escalation and Dose Expansion: Assess immunogenicity of tisotumab vedotin by measuring and assessing Anti-drug Antibody (ADA)
Time Frame: Throughout and at the end of trial (up to 90 days after last dose of tisotumab vedotin)
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Summarized by descriptive statistics by trial part and dose
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Throughout and at the end of trial (up to 90 days after last dose of tisotumab vedotin)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Objective Response Rate (ORR) (based on RECIST 1.1)
Time Frame: Up to approximately 6 months after the first dose of tisotumab vedotin
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ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR)
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Up to approximately 6 months after the first dose of tisotumab vedotin
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Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Duration of Response (DOR) (based on RECIST 1.1)
Time Frame: Up to approximately 6 months after the first dose of tisotumab vedotin
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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.
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Up to approximately 6 months after the first dose of tisotumab vedotin
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Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Time to Response (TTR) (based on RECIST 1.1)
Time Frame: Up to approximately 6 months after the first dose of tisotumab vedotin
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TTR for a responder is defined as the time from the start of treatment with study drug to the first objective tumor response observed.
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Up to approximately 6 months after the first dose of tisotumab vedotin
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Keiichi Fujiwara, Professor, Saitama Medical University International Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 27, 2019
Primary Completion (ACTUAL)
August 14, 2020
Study Completion (ACTUAL)
October 30, 2021
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (ACTUAL)
April 12, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 23, 2022
Last Update Submitted That Met QC Criteria
June 17, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCT1015-06
- JapicCTI-194639 (REGISTRY: JAPIC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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