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Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT02988817•Genmab

View on ClinicalTrials.gov

Summary

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST).
•3. For the expansion patients must provide a tumor tissue sample from archival tissue or fresh biopsy at enrolment
•4. Age ≥ 18 years.
•5. Acceptable renal function
•6. Acceptable liver function
•7. Acceptable hematological status
•8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•9. Life expectancy of at least three months.
•10. 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
+1 more criteria

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.
+23 more criteria

Locations (41)

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

Key Dates

Start Date

November 23, 2016

Primary Completion Date

November 12, 2021

Completion Date

November 12, 2021

Last Updated

August 1, 2023

Enrollment

306

ACTUAL participants

Conditions

Ovarian CancerCervical CancerEndometrial CancerNon Small Cell Lung Cancer (NSCLC)Thyroid CancerMelanomaSarcomaSolid Tumors

Interventions

Enapotamab vedotin (HuMax-AXL-ADC)

BIOLOGICAL

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)