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BRIEF TITLE: Trial 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

Dose-escalating and Cohort Expansion Safety Trial 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: GEN702
  • Secondary ID:
  • NCT ID: NCT02552121
  • NCT Alias:
  • Sponsor: Genmab - Industry
  • Source: Genmab

Brief Summary

The purpose of the trial is to establish the tolerability of tisotumab vedotin (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 tisotumab vedotin (HuMax-TF-ADC) in 28 day
treatment cycles.

In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose
of tisotumab vedotin (HuMax-TF-ADC) as determined in Part 1

Overal Status Start Date Phase Study Type
Recruiting Start Date: October 2015 Phase 1/Phase 2 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: An expected average of 6 month

Condition:

  • Ovary Cancer
  • Cervix Cancer
  • Endometrium Cancer
  • Bladder Cancer
  • Prostate Cancer (CRPC)
  • Esophagus Cancer
  • Lung Cancer (NSCLC)

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.

- Therapeutic anti-coagulative or long term anti-platelet treatment.

- 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.

- 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.
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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: Charlotte Langer

Phone: +4533779518

Email: c.langer@genmab.com

Locations

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

Institut Jules Bordet
Bruxelles, Brussels 1000
Belgium
Recruiting Joseph Kerger, MD

Universitaire Ziekenhuizen Leuven
Leuven, Flemish Brabant 3000
Belgium
Not yet recruiting Nicole Concin, MD

Grand Hôpital de Charleroi
Charleroi, Hainaut 6000
Belgium
Recruiting Jean-Luc Canon, MD

CHU de Liège
Liege, Liège 4000
Belgium
Recruiting Christine Gennigens, MD

CHU UCL Namur - site Godinne
Yvoir, Namur 5530
Belgium
Recruiting Lionel D'Hondt, MD

Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Not yet recruiting Jean-François Baurain, MD

CHU UCL Namur - Sainte Elisabeth
Namur, 5000
Belgium
Recruiting Peter Vuylsteke, MD

Rigshospitalet, Copenhagen University Hospital
Copenhagen, DK-2100
Denmark
Recruiting Ulrik Lassen, MD

Petz Aladár Megyei Oktató Kórház
Gyor, Gyor-Moson-Sopron 9023
Hungary
Not yet recruiting Tamás Pintér, MD

Debreceni Egyetem Klinikai Központ
Debrecen, Hajdu-Bihar 4032
Hungary
Not yet recruiting Róbert Póka, MD

Semmelweis Egyetem Onkológiai Központ
Budapest, 1083
Hungary
Not yet recruiting Magdolna Dank, MD

University College London Hospitals NHS Foundation Trust
London, England NW1 2PG
United Kingdom
Not yet recruiting Rebecca Kristeleit, MD

Sarah Cannon Cancer Center
London, England W1G 6AD
United Kingdom
Not yet recruiting Hendrik-Tobias Arkenau, MD

The Christie NHS Foundation Trust
Manchester, England M20 4BX
United Kingdom
Recruiting Emma Dean, MD

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