The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors.
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 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)
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
Name: Johann de Bono, Professor
Role: Principal Investigator
Affiliation: The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
Name: Line T Enevoldsen
Phone: +4531440615
Email: lte@genmab.com
