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GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors

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ClinicalTrials.gov Identifier: NCT03576131
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Genmab

Brief Summary:
The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors

Condition or disease Intervention/treatment Phase
Colorectal Cancer Non-small Cell Lung Cancer Triple Negative Breast Cancer Renal Cell Carcinoma Gastric Cancer Pancreatic Cancer Urothelial Cancer Biological: GEN1029 (HexaBody®-DR5/DR5) Phase 1 Phase 2

Detailed Description:
The trial is an open-label, multi-center safety trial of GEN1029 (HexaBody®-DR5/DR5). The trial consists of two parts a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: GEN1029 (HexaBody®-DR5/DR5)
Open label, single arm trial where GEN1029 will be administered
Biological: GEN1029 (HexaBody®-DR5/DR5)
GEN1029 will be administered intravenously once every 14 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) [ Time Frame: DLTs will be identified from the two first treatment cycles (28 days, a cycle is 14 days) ]
    To determine recommended phase 2a dose of GEN1029

  2. Adverse events (AEs) [ Time Frame: Throughout and at the end of trial (up to 24 months after first treatment cycle (a treatment cycle is 14 days)) ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (main):

  • Patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial.
  • Patient must be ≥ 18 years of age
  • Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
  • Have an acceptable hematological status
  • Have an acceptable renal function
  • Have an acceptable liver function
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1
  • Body weight ≥ 40kg
  • Patients both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after last infusion of GEN1029

Exclusion Criteria (main):

  • Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first GEN1029 administration
  • Have clinically significant cardiac disease
  • Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
  • 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 Investigational Medicinal Product (IMP)
  • Have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first GEN1029 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
  • Radiotherapy within 14 days prior to first GEN1029 administration
  • Any prior therapy with a compound targeting DR4 or DR5
  • History of chronic liver disease or evidence of hepatic cirrhosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576131


Contacts
Contact: Genmab Trial Information +45 70202728 clinicaltrials@genmab.com

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
United States, Texas
UT M.D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Spain
Hospital Univeritario Vall d'Hebron Recruiting
Barcelona, Spain
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, United Kingdom
The Royal Mardsen NHS Foundation Trust Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Genmab
Investigators
Principal Investigator: Ruth Plummer, Professor Newcastle Hospitals NHS Foundation Trust

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT03576131     History of Changes
Other Study ID Numbers: GCT1029-01
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial