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Ovary CancerPhase 1/2NCT02552121

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors

A Phase 1/2 study testing Tisotumab vedotin (HuMax-TF-ADC) in people with Ovary Cancer and Cervix Cancer, run by Seagen Inc. at 16 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ovary Cancer, Cervix Cancer, Endometrium Cancer
What is being tested?
Tisotumab vedotin (HuMax-TF-ADC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
16 sitesin 5 countries
Study dates
30 Nov 2015to 13 Dec 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy.
  • Patients must have measurable disease according to RECIST v1.1
  • Age ≥ 18 years.
  • Acceptable renal function.
  • Acceptable liver function.
  • Acceptable hematological status (hematologic support allowed under certain circumstances).
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  • Acceptable coagulation status.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least three months.
  • A negative serum pregnancy test (if female and aged between 18-55 years old).
  • Women who are pregnant or breast feeding are not to be included.
  • Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of HuMax-TF-ADC.
  • Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.

Who cannot join

  • Known past or current coagulation defects.
  • Diffuse alveolar hemorrhage from vasculitis.
  • Known bleeding diathesis.
  • Ongoing major bleeding.
  • Trauma with increased risk of life-threatening bleeding.
  • Have clinically significant cardiac disease.
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  • A baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block.
  • Therapeutic anti-coagulative or long term anti-platelet treatment except use of low dose acetylsalicylic acid (ASA) up to 81 mg/day and non-ASA nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.
  • Have received a cumulative dose of corticosteroid ≥ 150 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.
  • No dietary supplements allowed during the study period, except multivitamins, vitamin D and calcium.
  • Major surgery within six weeks or open biopsy within 14 days before drug infusion.
  • Plan for any major surgery during treatment period.
  • Patients not willing or able to have a pre-trial tumor biopsy taken (the screening biopsy can be omitted if archived material is available).
  • Presence or anticipated requirement of epidural catheter in relation to infusions (within 48 hours before and after dose of trial drug).
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
  • Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within four weeks or five half lives, whichever is longest, before first infusion.
  • Prior treatment with bevacizumab within twelve weeks before the first infusion.
  • Prior therapy with a conjugated or unconjugated auristatin derivative.
  • Radiotherapy within 28 days prior to first dose.
  • Patients who have not recovered from symptomatic side effects of radiotherapy at the time of initiation of screening procedure.
  • Known past or current malignancy other than inclusion diagnosis, except for:
  • Cervical carcinoma of Stage 1B or less.
  • Non-invasive basal cell or squamous cell skin carcinoma.
  • Non-invasive, superficial bladder cancer.
  • Prostate cancer with a current PSA level < 0.1 ng/mL.
  • Breast cancer in BRCA1 or BRACA2 positive ovarian cancer patients.
  • Any curable cancer with a complete response (CR) of > 5 years duration.
  • Radiographic evidence of cavitating pulmonary lesions and tumor adjacent to or invading any large blood vessel unless approved by sponsor.
  • Ongoing, significant , uncontrolled medical condition.
  • Presence of peripheral neuropathy.
  • Active viral, bacterial or fungal infection requiring intravenous treatment with antimicrobial therapy starting less than four weeks prior to first dose.
  • Oral treatment with antimicrobial therapy starting less than two weeks prior to first dose.
  • Known human immunodeficiency virus seropositivity.
  • Positive serology (unless due to vaccination or passive immunization due to Ig therapy) for hepatitis B.
  • Positive serology for hepatitis C based on test at screening.
  • Inflammatory bowel disease including Crohn's disease and colitis ulcerosa.
  • Inflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.
  • Ongoing acute or chronic inflammatory skin disease.
  • Active ocular surface disease at baseline (based on ophthalmological evaluation).
  • History of cicatricial conjunctivitis (as evaluated by an ophthalmologist).

Trial locations and contacts

16 sites in 5 countries.

16 sites in 5 countries

Belgium7 sites

  • Institut Jules Bordet

    Brussels, Brussels Capital, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut, 6000

  • Universitaire Ziekenhuizen Leuven

    Leuven, Flemish Brabant, 3000

  • CHU de Liège

    Liège, Liège, 4000

  • CHU UCL Namur - Sainte Elisabeth

    Namur, 5000

  • CHU UCL Namur - site Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

United Kingdom4 sites

  • University College London Hospitals NHS Foundation Trust

    London, England, NW1 2PG

  • Sarah Cannon Cancer Center

    London, England, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Hungary3 sites

  • Semmelweis Egyetem Onkológiai Központ

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, 4032

  • Petz Aladár Megyei Oktató Kórház

    Győr, Győr-Moson-Sopron, 9023

Other trials in Hungary

United States1 site

  • MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

Denmark1 site

  • Rigshospitalet, Copenhagen University Hospital

    Copenhagen, DK-2100

Other trials in Denmark

About this study

Official title: Dose-escalating and Cohort Expansion Safety Trial of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax®-TF-ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors.

Read the detailed description

The study is conducted in two parts. In the Dose Escalation portion of the trial, subjects are enrolled into cohorts at increasing dose levels of tisotumab vedotin (HuMax-TF-ADC) in 28 day treatment cycles.

The Cohort Expansion portion of the trial will further explore the recommended phase 2 dose of tisotumab vedotin (HuMax-TF-ADC) as determined in Part 1.

Being tested
Tisotumab vedotin (HuMax-TF-ADC)
Keywords
ovary cancer, cervix cancer, endometrium cancer, bladder cancer, prostate cancer (CRPC), esophagus cancer, lung cancer (NSCLC)
Medical subject headings
Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms, Esophageal Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tisotumab vedotin (HuMax-TF-ADC)Drug

Study groups in NCT02552121
Study groupRoleWhat they receive
Tisotumab vedotin (HuMax-TF-ADC)ExperimentalNot described
Receives: Drug: Tisotumab vedotin (HuMax-TF-ADC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  2. Part 2: Number of Participants Who Experience at Least One Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  3. Part 1: Number of Participants Who Experienced at Least One or More Serious Adverse Event (SAE)

    A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:

    Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

    Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  4. Part 2: Number of Participants Reporting One or More Serious Adverse Events (SAE)

    A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:

    Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

    Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  5. Part 1: Number of Participants Reporting One or More Infusion-related Adverse Events

    An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.

    Measured: Day 1, Day 8 & Day 15 (+1 day) until end of treatment (Part 1), approximately 48 weeks

  6. Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events

    An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.

    Measured: Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks

  7. Part 1: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events

    A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  8. Part 2: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events

    A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  9. Part 1: Number of Participants Reporting One or More Treatment-related Adverse Events

    A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  10. Part 2: Number of Participants Reporting One or More Treatment-related Adverse Events

    A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

Secondary outcomes (52)

  1. Part 1: Number of Participants With Markedly Abnormal Laboratory Values

    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  2. Part 2: Number of Participants With Markedly Abnormal Laboratory Values

    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  3. Part 1: Number of Participants Who Experienced a Skin Rash

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  4. Part 2: Number of Participants Who Experienced a Skin Rash

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  5. Part 1: Number of Participants Who Experienced a Bleeding Event

    Measured: Baseline to end of trial (Part 1), up to 72 weeks

  6. Part 2: Number of Participants Who Experienced a Bleeding Event

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  7. Part 1: Number of Participants Who Experienced a Neuropathy Event

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  8. Part 2: Number of Participants Who Experienced a Neuropathy Event

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  9. Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), + 24 hours 3rd infusion (Day 16), + 72 hours 3rd infusion (Day 18), + 168 hours 3rd infusion (Day 22) of Cycle 1

  10. Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  11. Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)

    Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), +168 hours 3rd infusion (Day 22) of Cycle 1

  12. Part 1: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  13. Part 2: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  14. Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  15. Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  16. Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab Vedotin (HuMax-TF-ADC)

    Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.

    Measured: Before infusion of Day 1, 8 and 15 of Cycle 1

  17. Part 1: Terminal Phase Elimination Half-life (T1/2) for Tisotumab Vedotin (HuMax-TF-ADC)

    Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  18. Part 1: Total Clearance (CL) of Tisotumab Vedotin (HuMax-TF-ADC)

    Data is only available for Part 1, for Part 2 inadequate pharmacokinetic samples were collected after the third dose to define a terminal phase, and therefore CL could not be determined.

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  19. Part 1: Apparent Volume of Distribution (Vz) for Tisotumab Vedotin (HuMax-TF-ADC)

    Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore Vz could not be determined.

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  20. Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  21. Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  22. Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Total HuMax-TF (Conjugated and Non-conjugated)

    Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  23. Part 1: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  24. Part 2: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  25. Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  26. Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  27. Part 1: Terminal Phase Elimination Half-life (T1/2) for Total HuMax-TF (Conjugated and Non-conjugated)

    Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  28. Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)

    CL could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.

    Measured: 0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1

  29. Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Conjugated and Non-conjugated)

    Vz could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.

    Measured: 0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1

  30. Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)

    Data is only available for Part 1, for Part 2, inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.

    Measured: Before infusion on Day 1, 8 and 15 of Cycle 1

  31. Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  32. Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  33. Part 1: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  34. Part 2: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  35. Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)

    Measured: Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

  36. Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)

    Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).

    Measured: Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1

  37. Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Free Toxin (MMAE)

    Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.

    Measured: Before infusion on Day 1, 8 and 15 of Cycle 1

  38. Part 1: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result

    Measured: Baseline to end of follow-up; maximum follow-up was 24 weeks

  39. Part 2: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  40. Part 1: Number of Patients Who Experienced Anti-tumor Activity Measured by Tumor Shrinkage

    Measured: Baseline to end of trial (Part 1), up to 72 weeks

  41. Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  42. Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen [Prostate Cancer]): Percentage Change From Baseline to End of Study

    Measured: Baseline to end of follow-up; maximum follow-up was 24 weeks

  43. Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study

    Measured: Baseline to end of follow-up; maximum follow-up was 24 weeks

  44. Part 2: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study

    Measured: Baseline to end of trial (Part 2), up to 36 week

  45. Part 1: Best Overall Response (OR)

    Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).

    Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.

    Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

    Measured: Baseline to end of trial (Part 1), up to 72 weeks

  46. Part 2: Best Overall Response (OR)

    Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).

    Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.

    Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  47. Part 1: Number of Participants Who Experienced Disease Control

    Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.

    Measured: 6, 12, 24 and 36 weeks post first infusion (Part 1)

  48. Part 2: Number of Participants Who Experienced Disease Control

    Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.

    Measured: 6, 12, 24 and 36 weeks post first infusion (Part 2)

  49. Part 1: Progression Free Survival (PFS)

    Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.

    Measured: Baseline to end of follow-up; maximum time of follow-up was 24 weeks

  50. Part 2: Progression Free Survival (PFS)

    Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

  51. Part 1: Duration of Response

    Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.

    Measured: Baseline to end of trial (Part 1), up to 72 weeks

  52. Part 2: Duration of Response

    Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.

    Measured: Baseline to end of trial (Part 2), up to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2015 (estimated)
  2. Study start30 Nov 2015
  3. Primary completion13 Dec 2017
  4. Study completion13 Dec 2017

Resources

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
Sequential
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02552121
Sponsor's protocol ID
GEN702
Other IDs
innovaTV 202
Status last verified
Mar 2021
First submitted
14 Sep 2015
Last updated
8 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • Feng S, Gunawan R, Passey C, Voellinger J, Polhamus D, Gerritsen A, O'Day C, Carret AS, Soumaoro I, Gupta M, Hanley WD. Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. J Pharmacokinet Pharmacodyn. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w.

    PubMed 41044356

  • Passey C, Voellinger J, Gibiansky L, Gunawan R, Nicacio L, Soumaoro I, Hanley WD, Winter H, Gupta M. Exposure-safety and exposure-efficacy analyses for tisotumab vedotin for patients with locally advanced or metastatic solid tumors. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1262-1273. doi: 10.1002/psp4.13007. Epub 2023 Jul 26.

    PubMed 37496366

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tisotumab vedotin (HuMax-TF-ADC) in people with Ovary Cancer and Cervix Cancer, run by Seagen Inc. at 16 sites in 5 countries.

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 13 inclusion and 41 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Belgium, United Kingdom, Hungary, United States, Denmark. 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?

Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Number of Participants Who Experience at Least One Adverse Event (AE) (time frame: Baseline to end of follow-up; maximum time of follow-up was 24 weeks). The study lists 10 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 NCT02552121, which also lists 2 linked publications.

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 8 Apr 2021.

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