Clinical Trials /

A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

NCT03913741

Description:

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

Related Conditions:
  • Cervical Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
  • Official Title: Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Clinical Trial IDs

  • ORG STUDY ID: GCT1015-06
  • SECONDARY ID: innovaTV 206
  • NCT ID: NCT03913741

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
tisotumab vedotinExperimental tisotumab vedotin

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
Experimental tisotumab vedotinExperimentalOpen label, single arm trial where tisotumab vedotin will be administered
  • tisotumab vedotin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description:Summarized by descriptive statistics by trial part and dose

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR)
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:TTR for a responder is defined as the time from the start of treatment with study drug to the first objective tumor response observed.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genmab

Trial Keywords

  • tisotumab vedotin
  • cervical cancer

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