Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
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.
Checked against the public recordLast updated Apr 8, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Seagen Inc.
- Interventions being studied
- Drug: Tisotumab vedotin (HuMax-TF-ADC)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: \- 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. Exclusion Criteria: * 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. * 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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- MD Anderson Cancer CenterHouston, Texas
- Institut Jules BordetBrussels, Brussels Capital
- Universitaire Ziekenhuizen LeuvenLeuven, Flemish Brabant
- Grand Hôpital de CharleroiCharleroi, Hainaut
- CHU de LiègeLiège, Liège
- CHU UCL Namur - site GodinneYvoir, Namur
- Cliniques Universitaires Saint-LucBrussels
- CHU UCL Namur - Sainte ElisabethNamur
- Rigshospitalet, Copenhagen University HospitalCopenhagen
- Petz Aladár Megyei Oktató KórházGyőr, Győr-Moson-Sopron
- Debreceni Egyetem Klinikai KözpontDebrecen, Hajdú-Bihar
- Semmelweis Egyetem Onkológiai KözpontBudapest
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 8, 2021. Always confirm current availability with the study team.