Breast Cancer Clinical Trial
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
The purpose of the trial is to evaluate the safety of GEN1029 (HexaBodyÂ®-DR5/DR5) in a mixed population of patients with specified solid tumors
The trial is an open-label, multi-center first-in-human 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.
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
Have uncontrolled hypertension as defined in the protocol
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
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There are 2 Locations for this study
New Haven Connecticut, 06510, United States
Houston Texas, 77030, United States
Barcelona , , Spain
Madrid , , Spain
Newcastle , , United Kingdom
Sutton , , United Kingdom
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