Clinical Trials /

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

Related Conditions:
  • Malignant Solid Tumor
  • Ovarian Carcinoma
Recruiting Status:

Active, not recruiting


Phase 1/Phase 2

Trial Eligibility



  • Brief Title: Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: GCT1021-01
  • NCT ID: NCT02988817


  • Ovarian Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Non Small Cell Lung Cancer
  • Thyroid Cancer
  • Melanoma
  • Sarcoma


Enapotamab vedotin (HuMax-AXL-ADC)Enapotamab vedotin (HuMax-AXL-ADC)


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

Detailed Description

      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

Trial Arms

Enapotamab vedotin (HuMax-AXL-ADC)ExperimentalAll arms of the trial (both in escalation and expansion phase) will be administered enapotamab vedotin (HuMax-AXL-ADC)
  • Enapotamab vedotin (HuMax-AXL-ADC)

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. For the expansion part: Patients with relapsed, advanced and/or metastatic solid
             tumors who are not candidates for standard therapy

          3. Patients must have measurable disease according to Response Evaluation Criteria In
             Solid Tumors (RECIST).

          4. For the expansion patients must provide a fresh tumor biopsy at enrolment

          5. Age ≥ 18 years.

          6. Acceptable renal function

          7. Acceptable liver function

          8. Acceptable hematological status

          9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

         10. Life expectancy of at least three months.

         11. 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

         12. Patients must provide a signed informed consent form before any trial relates
             activities are carried out.

        Exclusion Criteria:

          1. Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for
             at least 4 weeks prior to first IMP administration.

          2. Have clinically significant cardiac disease

          3. 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.

          4. Uncontrolled hypertension

          5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage
             colony stimulating factor support 3 weeks prior to first IMP administration.

          6. 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.

          7. 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

          8. Major surgery within four weeks before first IMP administration.

          9. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain
             metastases or stroke.

         10. 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.

         11. Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding
             site targeting payload.

         12. Radiotherapy within 14 days prior to first IMP administration.

         13. 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.

               -  Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients.

               -  Any curable cancer with a complete response (CR) of > 2 years duration.

         14. Melanoma patients with an LDH ≥ 3 x ULN.

         15. Ongoing significant, uncontrolled medical condition including:

             o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.

         16. Grade 2 or higher peripheral neuropathy.

         17. Clinically significant active viral, bacterial or fungal infection

         18. Known human immunodeficiency virus seropositivity.

         19. Known positive serology for hepatitis B (unless due to vaccination or passive
             immunization due to immunoglobulin therapy)

         20. Known positive serology for hepatitis C (unless due to immunoglobulin therapy)

         21. Substance abuse, medical, psychological or social conditions that may interfere with
             the patient's participation in the trial or evaluation of the trial result

         22. 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

         23. Body weight < 40 kg

         24. Women who are pregnant or breast feeding.

         25. Pulmonary hemorrhage or hemoptysis > 2.5 ml blood within 6 weeks unless cause has been
             addressed and is medically resolved.

         26. History of acute pneumonitis.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities (DLTs)
Time Frame:Dose Limiting Toxicities will be assessed from first treatment cycle (3 or 4 weeks)
Safety Issue:
Description:As this is a phase I trial the main objective is to assess the recommended phase 2 dose of enapotamab vedotin (HuMax-AXL-ADC)

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) parameters, Cmax
Time Frame:At end of trial (up to 10 months)
Safety Issue:
Measure:Anti-tumor activity measured by tumor shrinkage (based on computerized tomography [CT]-scan evaluations), change in Cancer Antigen (CA) 125.
Time Frame:At end of trial (up to 12 months)
Safety Issue:
Measure:Pharmacokinetic (PK) parameters, AUC
Time Frame:At end of trial (up to 10 months)
Safety Issue:


Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Genmab

Last Updated

July 2, 2021