Ovarian Cancer Clinical Trial
Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
The trial consists of two parts; a dose escalation part (phase I, first in-human (FIH)) and an expansion part (phase IIa).
The dose escalation part has 2 dosing schedules: 1 dose every 3 weeks (1Q3W) dose regimen, and 3 doses every 4 weeks (3Q4W) dosing regimen.
The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part.
For the dose escalation part: Patients with selected, relapsed or refractory solid tumors who have failed available standard therapy or who are not candidates for standard therapy. For the expansion part: Patients with advanced and/or metastatic solid tumors who are not candidates for standard therapy
Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST).
For the expansion patients must provide a tumor tissue sample from archival tissue or fresh biopsy at enrolment
Age ≥ 18 years.
Acceptable renal function
Acceptable liver function
Acceptable hematological status
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least three months.
Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last infusion of HuMax-AXL-ADC
Patients must provide a signed informed consent form before any trial relates activities are carried out.
Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 4 weeks prior to first IMP administration.
Have clinically significant cardiac disease
Known congestive heart failure and/ or a known decreased cardiac ejection fraction of < 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) > 480 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 3 weeks prior to first IMP administration.
Have received a cumulative dose of corticosteroid > 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first Investigational Medicinal Product (IMP) administration.
History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial.
Major surgery within four weeks before first IMP administration.
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 five half-lives but maximum four weeks before first infusion. Accepted exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist.
Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
Radiotherapy within 14 days prior to first IMP administration.
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 prostate specific antigen (PSA) level < 0.1 ng/mL.
Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients.
Any curable cancer with a complete response (CR) of > 2 years duration.
Melanoma patients with an lactate dehydrogenase (LDH) ≥ 3 x upper limit normal (ULN).
Ongoing significant, uncontrolled medical condition including:
o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
Grade 2 or higher peripheral neuropathy.
Clinically significant active viral, bacterial or fungal infection
Known human immunodeficiency virus seropositivity.
Known positive serology for hepatitis B (unless due to vaccination or passive immunization due to immunoglobulin therapy)
Known positive serology for hepatitis C (unless due to immunoglobulin therapy)
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result
History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of IMP
Body weight < 40 kg
Women who are pregnant or breast feeding.
Pulmonary hemorrhage or hemoptysis > 2.5 ml blood within 6 weeks unless cause has been addressed and is medically resolved.
History of acute pneumonitis.
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There are 40 Locations for this study
Phoenix Arizona, 85054, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06520, United States
Jacksonville Florida, 32224, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
New York New York, 10034, United States
Durham North Carolina, 27710, United States
Philadelphia Pennsylvania, 19111, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Madison Wisconsin, 53792, United States
Leuven Flemish Brabant, 3000, Belgium
Bruxelles , 1200, Belgium
Jette , 1090, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Copenhagen , DK-21, Denmark
Amsterdam , 1066, Netherlands
Leiden , 2333, Netherlands
Rotterdam , 3015, Netherlands
Utrecht , 3584, Netherlands
Barcelona , 08035, Spain
Barcelona , 08909, Spain
Girona , 17007, Spain
Madrid , 28041, Spain
Málaga , 29016, Spain
Zaragoza , 50009, Spain
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle , NE7 7, United Kingdom
Sutton , SM2 5, United Kingdom
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