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), Squamous Cell Carcinoma of the Head and Neck (SCCHN)

In brief

The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors.

Key facts

Study ID

NCT02001623

Run by

Seagen Inc.

People needed

195

Starts

2013-11-30

Expected to finish

2019-05-02

Last updated by the study team

2021-12-29

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
• 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.

You may not qualify if…

• Known past or current coagulation defects.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.