Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies (innovaTV 206)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03913741
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Genmab

Brief Summary:
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: tisotumab vedotin Phase 1 Phase 2

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

Layout table for study information
Study Type : Interventional
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
Experimental: Experimental tisotumab vedotin
Open label, single arm trial where tisotumab vedotin will be administered
Drug: tisotumab vedotin
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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) ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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


Secondary Outcome Measures :
  1. 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 ]
    ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR)

  2. 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 ]
    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.

  3. 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 ]
    TTR for a responder is defined as the time from the start of treatment with study drug to the first objective tumor response observed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913741


Contacts
Layout table for location contacts
Contact: Genmab A/S Trial Information +45 70202728 clinicaltrials@genmab.com

Locations
Layout table for location information
Japan
National Cancer Center Hospital Recruiting
Tokyo, Japan
Contact: Kan Yonemori, MD         
Principal Investigator: Kan Yonemori, MD         
National Cancer Center Hosptial East Recruiting
Tokyo, Japan
Contact: Yasutoshi Kuboki, MD         
Principal Investigator: Yasutoshi Kuboki, MD         
Sponsors and Collaborators
Genmab
Seattle Genetics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Keiichi Fujiwara, Professor Saitama Medical University International Medical Center

Additional Information:
Layout table for additonal information
Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT03913741     History of Changes
Other Study ID Numbers: GCT1015-06
innovaTV 206 ( Other Identifier: Genmab )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Genmab:
tisotumab vedotin
cervical cancer