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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTisotumab Vedotin (HuMax-TF-ADC)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 29, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?29 U.S. locations

Locations may change over time.

Who runs it?Seagen Inc.

Study sponsor

Study overview

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)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
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.

Reasons someone may not be able to joinExclusion criteria

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California Irvine Medical Center (UCIMC)Orange, California
Yale Cancer CenterNew Haven, Connecticut
University of MiamiMiami, Florida
University Gynecologic OncologyAtlanta, Georgia
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada
Sarah Cannon Research InstituteNashville, Tennessee
MD Anderson Cancer CenterHouston, Texas
University of VirginiaCharlottesville, Virginia
Universitair Ziekenhuis AntwerpenEdegem, Antwerpen
Universitair Ziekenhuis LeuvenLeuven, Flemish Brabant
Grand Hôpital de CharleroiCharleroi, Hainaut
Centre Hospitalier Universitaire Ambroise ParéMons, Hainaut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 29, 2021. Always confirm current availability with the study team.

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