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

Completed · Phase 1/Phase 2

Conditions studied: Ovary Cancer, Cervix Cancer, Endometrium Cancer, Bladder Cancer, Prostate Cancer (CRPC), Esophagus Cancer, Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT02552121

Run by

Seagen Inc.

People needed

33

Starts

2015-11-30

Expected to finish

2017-12-13

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States
• Institut Jules Bordet — Brussels, Brussels Capital, Belgium
• Universitaire Ziekenhuizen Leuven — Leuven, Flemish Brabant, Belgium
• Grand Hôpital de Charleroi — Charleroi, Hainaut, Belgium
• CHU de Liège — Liège, Liège, Belgium
• CHU UCL Namur - site Godinne — Yvoir, Namur, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• CHU UCL Namur - Sainte Elisabeth — Namur, Belgium
• Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark
• Petz Aladár Megyei Oktató Kórház — Győr, Győr-Moson-Sopron, Hungary
• Debreceni Egyetem Klinikai Központ — Debrecen, Hajdú-Bihar, Hungary
• Semmelweis Egyetem Onkológiai Központ — Budapest, Hungary
• University College London Hospitals NHS Foundation Trust — London, England, United Kingdom
• Sarah Cannon Cancer Center — London, England, United Kingdom
• The Christie NHS Foundation Trust — Manchester, England, United Kingdom
• The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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