Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
NCT ID: NCT02001623
Last Updated: 2021-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
195 participants
INTERVENTIONAL
2013-11-30
2019-05-02
Brief Summary
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Detailed Description
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In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose of HuMax-TF-ADC as determined in Part 1
Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tisotumab Vedotin (HuMax-TF-ADC)
All arms of the trial (borh in escalation and expansion phase) will be administered tisotumab vedotin (HuMax-TF-ADC)
Tisotumab Vedotin (HuMax-TF-ADC)
Interventions
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Tisotumab Vedotin (HuMax-TF-ADC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Patients must have measurable disease
* Age ≥ 18 years.
* Acceptable renal function
* Acceptable liver function
* Acceptable hematological status (without hematologic support
* 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.
Exclusion Criteria
* Ongoing major bleeding,
* Have clinically significant cardiac disease
* 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.
* 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 ≥ 100 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.
* Major surgery within six weeks or open biopsy within 14 days before drug infusion.
* Plan for any major surgery during treatment period.
* 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.
* 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.
* Any curable cancer with a complete response (CR) of \> 5 years duration.
* 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.
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johann de Bono, Professor
Role: PRINCIPAL_INVESTIGATOR
The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
Locations
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University of California Irvine Medical Center (UCIMC)
Orange, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
University Gynecologic Oncology
Atlanta, Georgia, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
Centre Hospitalier Universitaire Ambroise Paré
Mons, Hainaut, Belgium
CHU UCL Namur - site Godinne
Yvoir, Namur, Belgium
Saint-Luc University Hospital
Brussels, , Belgium
CHU de Liège
Liège, , Belgium
CHU UCL Namur - Sainte Elisabeth
Namur, , Belgium
Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Herlev, , Denmark
Karolinska Universitetssjukhuset
Stockholm, Solna, Sweden
Lungemedicinska Kliniken
Linköping, , Sweden
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom
University College London Hospitals
London, England, United Kingdom
Sarah Cannon Research Institute - London
London, England, United Kingdom
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, Newcastle, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Velindre NHS Trust
Cardiff, Wales, United Kingdom
Beatson Cancer Centre
Glasgow, , United Kingdom
Guys hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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de Bono JS, Concin N, Hong DS, Thistlethwaite FC, Machiels JP, Arkenau HT, Plummer R, Jones RH, Nielsen D, Windfeld K, Ghatta S, Slomovitz BM, Spicer JF, Yachnin J, Ang JE, Mau-Sorensen PM, Forster MD, Collins D, Dean E, Rangwala RA, Lassen U. Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): a first-in-human, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Mar;20(3):383-393. doi: 10.1016/S1470-2045(18)30859-3. Epub 2019 Feb 8.
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.
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.
Hong DS, Concin N, Vergote I, de Bono JS, Slomovitz BM, Drew Y, Arkenau HT, Machiels JP, Spicer JF, Jones R, Forster MD, Cornez N, Gennigens C, Johnson ML, Thistlethwaite FC, Rangwala RA, Ghatta S, Windfeld K, Harris JR, Lassen UN, Coleman RL. Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer. Clin Cancer Res. 2020 Mar 15;26(6):1220-1228. doi: 10.1158/1078-0432.CCR-19-2962. Epub 2019 Dec 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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innovaTV 201
Identifier Type: OTHER
Identifier Source: secondary_id
GEN701
Identifier Type: -
Identifier Source: org_study_id