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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03576131
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : July 14, 2021
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE July 3, 2018
Last Update Posted Date July 14, 2021
Actual Study Start Date  ICMJE May 7, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
Official Title  ICMJE First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Non-small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Renal Cell Carcinoma
  • Gastric Cancer
  • Pancreatic Cancer
  • Urothelial Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: GEN1029 (HexaBody®-DR5/DR5)
Open label, single arm trial where GEN1029 will be administered
Intervention: Biological: GEN1029 (HexaBody®-DR5/DR5)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2018)
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Genmab Trial Information +45 70202728
Listed Location Countries  ICMJE Spain,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03576131
Other Study ID Numbers  ICMJE GCT1029-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genmab
Study Sponsor  ICMJE Genmab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruth Plummer, Professor Newcastle Hospitals NHS Foundation Trust
PRS Account Genmab
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP