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Completed

NCT Number: NCT03913741

A 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

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Key information

Conditions

Solid Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center Hosptial East, Kashiwa-shi, Chiba, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tisotumab vedotin

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Collaborators

  • Seagen Inc.

Registry information

Official study title

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Acronym: innovaTV 206

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 12, 2019
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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