Solid TumorPhase 1/2innovaTV 206NCT03913741
A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
A Phase 1/2 study testing tisotumab vedotin in people with Solid Tumor, run by Genmab at 8 sites in Japan.
Trial summary
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- tisotumab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 8 sitesJapan
- Study dates
- 27 Feb 2019to 30 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
National Cancer Center Hospital
Chūōku, Tokyo-To, 104-0045
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, 350-1298
National Cancer Center Hosptial East
Kashiwa-shi, Chiba, 277-8577
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
NHO Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Keio University Hospital
Shinjuku-ku, Tokyo-To, 160-8582
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
Official title: 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
Read the 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
- Conditions
- Solid Tumor
- Being tested
- tisotumab vedotin
- Keywords
- tisotumab vedotin, cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tisotumab vedotinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental tisotumab vedotin | Experimental | Open label, single arm trial where tisotumab vedotin will be administered Receives: Drug: tisotumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation and Dose Expansion: Incidence of drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs) by CTCAE v5.0 [Safety]
Measured: 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]
Measured: 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
Measured: 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
Measured: 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))
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Throughout and at the end of trial (up to 90 days after last dose of tisotumab vedotin)
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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.
Measured: Up to approximately 6 months after the first dose of tisotumab vedotin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start27 Feb 2019
- Primary completion14 Aug 2020
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group assignment
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Keiichi Fujiwara, Professor, Principal investigator, Saitama Medical University International Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913741
- Sponsor's protocol ID
- GCT1015-06
- Other IDs
- JapicCTI-194639
- Acronym
- innovaTV 206
- Status last verified
- Dec 2021
- First submitted
- 29 Mar 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer Sci. 2022 Aug;113(8):2788-2797. doi: 10.1111/cas.15443. Epub 2022 Jun 15.
PubMed 35633184
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT03913741
- Acronym / sponsor ID
- innovaTV 206 / GCT1015-06
- Conditions
- Solid Tumor
- Keywords
- tisotumab vedotin, cervical cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental tisotumab vedotin | Experimental | Drug: tisotumab vedotinOpen label, single arm trial where tisotumab vedotin will be administered |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tisotumab vedotinTisotumab 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 | Drug | Experimental tisotumab vedotin |
Primary outcome
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)
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)
Time frame: 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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Results publication: PubMed 35633184Yonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer Sci. 2022 Aug;113(8):2788-2797. doi: 10.1111/cas.15443. Epub 2022 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keiichi Fujiwara, Professor principal investigator
Saitama Medical University International Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tisotumab vedotin in people with Solid Tumor, run by Genmab at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.