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BRIEF TITLE: Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor


  • Org Study ID: GEN701
  • Secondary ID:
  • NCT ID: NCT02001623
  • NCT Alias:
  • Sponsor: Genmab - Industry
  • Source: Genmab

Brief 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.

Detailed Description


The study is conducted in two parts. The dose escalation portion of the trial subjects are
enrolled into cohorts at increasing dose levels of HuMax-TF-ADC in 21 day treatment cycles.

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

Overal Status Start Date Phase Study Type
Recruiting Start Date: November 2013 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Adverse events measured throughout the study from first treatment until end of trial.

Primary Outcome 1 - Time Frame: After first treatment cycle (3 weeks) and at end of trial (an expected average of 6 months)

Condition:

  • 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)

Eligibility

Criteria:
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

- 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:

- 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Johann de Bono, Professor

Role: Principal Investigator

Affiliation: The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust

Overall Contact

Name: Line T Enevoldsen

Phone: +4531440615

Email: lte@genmab.com

Locations

Facility Status Contact
University of California Irvine Medical Center (UCIMC)
Orange, California 92868-3201
United States
Not yet recruiting Krishnansu Tewari, MD
714-456-8020
Yale Cancer Center
New Haven, Connecticut 06520
United States
Active, not recruiting
University of Miami
Miami, Florida 33136
United States
Recruiting Brian Slomovitz, MD

University Gynecologic Oncology
Atlanta, Georgia 30342
United States
Active, not recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Active, not recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Melissa Johnson, MD

MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting David S Hong, MD

University of Virginia
Charlottesville, Virginia 22908
United States
Recruiting Robert Dreicer, MD

Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen 2650
Belgium
Recruiting Christian Rolfo, MD

Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant 3000
Belgium
Recruiting Nicole Concin, MD

Grand Hôpital de Charleroi
Charleroi, Hainaut 6000
Belgium
Recruiting Jean-Luc Canon, MD
+3271934730
Centre Hospitalier Universitaire Ambroise Paré
Mons, Hainaut 7000
Belgium
Recruiting Stephane Holbrechts, MD
+3265392111
CHU UCL Namur - site Godinne
Yvoir, Namur 5530
Belgium
Recruiting Lionel D'Hondt, MD
+3281423858
Saint-Luc University Hospital
Brussels, 1200
Belgium
Recruiting Jean-Pascal Machiels, MD

CHU de Liège
Liège, 4000
Belgium
Recruiting Christine Gennigens, MD
+3243667111
CHU UCL Namur - Sainte Elisabeth
Namur, 5000
Belgium
Recruiting Jean-Charles Goeminne, MD
+3281720761
Rigshospitalet, Copenhagen University Hospital
Copenhagen, DK-2100
Denmark
Recruiting Ulrik Lassen, MD

Herlev and Gentofte Hospital
Herlev, 2730
Denmark
Recruiting Dorte Nielsen, MD

Karolinska Universitetssjukhuset
Stockholm, Solna 17176
Sweden
Recruiting Jeffrey Yachnin, MD

Lungemedicinska Kliniken
Linköping, 58185
Sweden
Recruiting Anders Vikström, MD

The Leeds Teaching Hospitals NHS Trust
Leeds, England LS9 7TF
United Kingdom
Recruiting Chris Twelves, MD
+441132068186
University College London Hospitals
London, England NW1 2BU
United Kingdom
Recruiting Martin Forster, MD

Sarah Cannon Research Institute - London
London, England W1G 6AD
United Kingdom
Recruiting Hendrik-Tobias Arkenau, MD
+4402032195251
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, Newcastle NE7 7DN
United Kingdom
Recruiting Ruth Plummer, MD

The Royal Marsden NHS Foundation Trust
Sutton, Surrey SM2 5PT
United Kingdom
Recruiting Johann de Bono, Professor

Velindre NHS Trust
Cardiff, Wales CF14 2TL
United Kingdom
Recruiting Robert Jones, MD
+4402920316209
Beatson Cancer Centre
Glasgow, G12 OYN
United Kingdom
Recruiting Robert Jones, MD

Guys hospital
London, SE1 9RT
United Kingdom
Recruiting James Spicer, MD

The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom
Recruiting Fiona Thistlethwaite, MD