Clinical Trials /

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

NCT03576131

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
  • Official Title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: GCT1029-01
  • NCT ID: NCT03576131

Conditions

  • Colorectal Cancer
  • Non-small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Renal Cell Carcinoma
  • Gastric Cancer
  • Pancreatic Cancer
  • Urothelial Cancer

Interventions

DrugSynonymsArms
GEN1029 (HexaBody®-DR5/DR5)GEN1029 (HexaBody®-DR5/DR5)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
GEN1029 (HexaBody®-DR5/DR5)ExperimentalOpen label, single arm trial where GEN1029 will be administered
  • GEN1029 (HexaBody®-DR5/DR5)

Eligibility 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
      
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:DLTs will be identified from the two first treatment cycles (28 days, a cycle is 14 days)
Safety Issue:
Description:To determine recommended phase 2a dose of GEN1029

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genmab

Last Updated

January 29, 2019