HuMax-AXL-ADC Safety Study in Patients With Solid Tumors



Status:Recruiting
Conditions:Lung Cancer, Skin Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer, Thyroid Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:December 2016
End Date:June 2021
Contact:Genmab A/S Trial Information
Email:clinicaltrials@genmab.com
Phone:+45 7020 2728

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First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (HuMax®-AXL-ADC) 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 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

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
trial.

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
IMP

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.
We found this trial at
19
sites
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Shirish Gadgeel, MD
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Mohammed Milhem, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Atlanta, Georgia 30308
Principal Investigator: Suresh Ramalingham, MD
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Aurora, Colorado 80045
Principal Investigator: Victor Villalobos, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Pasi Janne, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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665 Elm Street
Buffalo, New York 14263
Principal Investigator: Grace Dy, MD
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Dallas, Texas 75230
Principal Investigator: James Strauss, MD
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Jennifer Choe, MD
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Houston, Texas 77030
Principal Investigator: Sarina Piha-Paul, MD
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Jacksonville, Florida 32216
Principal Investigator: Steven Attia, MD
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Leuven, Flemish Brabant
Principal Investigator: Ignace Vergote, Professor
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Ticiana Ticiana, MD
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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New Haven, Connecticut 06520
Principal Investigator: Mario Sznol, MD
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New York, New York 10016
Principal Investigator: Luca Paoluzzi, MD
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New York, New York 10032
Principal Investigator: Mathew Ingham, MD
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Philadelphia, Pennsylvania 19111
Principal Investigator: Sujana Movva, MD
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Phoenix, Arizona 85054
Principal Investigator: Mahesh Seetharam, MD
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Aaron Mansfield, MD
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Salt Lake City, Utah 84112
Principal Investigator: Jonathan Whisenant, MD
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