Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Non Small Cell Lung Cancer (NSCLC), Thyroid Cancer, Melanoma, Sarcoma, Solid Tumors

In brief

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

Key facts

Study ID

NCT02988817

Run by

Genmab

People needed

306

Starts

2016-11-23

Expected to finish

2021-11-12

Last updated by the study team

2023-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Uncontrolled hypertension
• 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.

Where it is running

• Mayo Clinic - Phoenix — Phoenix, Arizona, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale University, Smilow Cancer Center at Yale New Haven Hospital — New Haven, Connecticut, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University School of Medicine, Winship Cancer Institute — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Mary Crowley Cancer Research Center — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States
• Universitair Ziekenhuizen Leuven — Leuven, Flemish Brabant, Belgium
• Institut Roi Albert II - Cliniques Universitaires Saint Luc — Brussels, Belgium
• Universitair Ziekenhuis Brussel - Oncologisch Centrum — Jette, Belgium
• Medische oncologie, Oncologisch Centrum - AZ Groeninge — Kortrijk, Belgium
• U.Z. Leuven Gasthuisberg, Department of General Medical Oncology — Leuven, Belgium

Full record on ClinicalTrials.gov

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