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Clinical Trial 20475

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT02988817

Phase: Phase I/II
Prinicipal Investigator: Andreas Saltos

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Study Title

First-in-Human, Open-Label, Dose-Escalation Trial with Expansion Cohorts to Evaluate Safety of Axl-Specific Antibody-Drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients with 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 two dose escalation arms: the first arm investigates a once every 3 weeks (1Q3W) dosing schedule and the second arm investigates a three administrations over 4 weeks (3Q4W) dosing schedule. The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in Part 1


Primary Objective: To determine the MTD and to establish the safety profile of enapotamab vedotin in amixed population of patients with specified solid tumors. Secondary Objectives: To evaluate the safety laboratory parameters of enapotamab vedotin in a mixed population of patients with specified solid tumors. To establish the PK profile and evaluate immunogenicity of enapotamab vedotin after single and multiple infusions. To evaluate the antitumor activity of enapotamab vedotin in a mixed population of patients with specified solid tumors. To evaluate Axl expression in tumor biopsies from a mixed population of patients with specified solid tumors. Exploratory Objective: To explore biomarkers predictive of response and resistance to enapotamab vedotin.




Enapotamab Vedotin ()

Inclusion Criteria

Inclusion Criteria:

  • For the dose escalation part: Patients with selected, relapsed solid tumors who have failed available standard therapy or who are not candidates for standard therapy.
  • For the expansion part: Patients with relapsed, 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 fresh tumor 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.

  • Exclusion Criteria

    Exclusion Criteria:

  • 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 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: (a) Cervical carcinoma of Stage 1B or less. (b) Non-invasive basal cell or squamous cell skin carcinoma. (c) Non-invasive, superficial bladder cancer. (d) Prostate cancer with a current PSA level 2 years duration.
  • Melanoma patients with an LDH ≥ 3 x ULN.
  • Ongoing significant, uncontrolled medical condition including: 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 > 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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