New Haven, Connecticut 06510

  • Urothelial Cancer

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


Study summary:

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.


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


NCT ID:

NCT03576131


Primary Contact:

Principal Investigator
Ruth Plummer, Professor
Newcastle Hospitals NHS Foundation Trust

Genmab Trial Information
Phone: +45 70202728
Email: clinicaltrials@genmab.com


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06510
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.