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Trial record 1 of 1 for:    gen701
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Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02001623
First Posted: December 5, 2013
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genmab
  Purpose
The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors

Condition Intervention Phase
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) Drug: Tisotumab Vedotin (HuMax-TF-ADC) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • Adverse events measured throughout the study from first treatment until end of trial. [ Time Frame: After first treatment cycle (3 weeks) and at end of trial (an expected average of 6 months) ]
    As this is a phase I trial the main objective is to assess the safety and tolerability of HuMax-TF-ADC throughout the treatment periods of the patients participating in the trial.


Secondary Outcome Measures:
  • PK profile of HuMax-TF-ADC after single and multiple infusions [ Time Frame: After first treatment cycle (3 weeks) and at end of trial (an expected average of 6 months) ]
  • Anti-tumor activity of HuMax-TF-ADC; tumor size (RECIST), PSA and/or CA-125 [ Time Frame: At end of trial (an expected average of 6 months) ]
    Evaluate the anti-tumor activity of HuMax-TF-ADC in a mixed population of patients with specified solid tumors.


Estimated Enrollment: 144
Study Start Date: November 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tisotumab Vedotin (HuMax-TF-ADC)
All arms of the trial (borh in escalation and expansion phase) will be administered tisotumab vedotin (HuMax-TF-ADC)
Drug: Tisotumab Vedotin (HuMax-TF-ADC)

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥ 100 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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001623


  Show 29 Study Locations
Sponsors and Collaborators
Genmab
Investigators
Principal Investigator: Johann de Bono, Professor The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT02001623     History of Changes
Other Study ID Numbers: GEN701
First Submitted: November 14, 2013
First Posted: December 5, 2013
Last Update Posted: July 2, 2017
Last Verified: April 2017

Keywords provided by Genmab:
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)

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Squamous Cell
Urinary Bladder Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases