HuMax®-TF-ADC Safety Study in Patients With Solid Tumors
Conditions
Ovary Cancer - Cervix Cancer - Endometrium Cancer - Bladder Cancer - Prostate Cancer (CRPC) - Esophagus Cancer - Lung Cancer(NSCLC)
Conditions: official terms
Endometrial Neoplasms - Ovarian Neoplasms - Prostatic Neoplasms - Urinary Bladder Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
ovary cancer, cervix cancer, endometrium cancer, bladder cancer, prostate cancer (CRPC), esophagus cancer, lung cancer(NSCLC)
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HuMax-TF-ADC
Type: Drug
Overall Status
Recruiting
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 in three different arms where at least two of the cancer types will be chosen for the Cohort Expansion.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: David S Hong, MD
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Status: Recruiting
Contact: Ulrik Lassen, MD
The Royal Marsden NHS Foundation Trust
Sueery, United Kingdom
Status: Recruiting
Contact: Johann de Bono, Professor
Start Date
November 2013
Completion Date
September 2017
Sponsors
Genmab
Source
Genmab
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page