GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 1, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Genmab
- Interventions being studied
- Biological: GEN1029 (HexaBody®-DR5/DR5)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- (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
- (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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yale UniversityNew Haven, Connecticut
- UT M.D Anderson Cancer CenterHouston, Texas
- Hospital Univeritario Vall d'HebronBarcelona
- START Madrid CIOCCMadrid
- The Newcastle upon Tyne Hospitals NHS Foundation TrustNewcastle
- The Royal Mardsen NHS Foundation TrustSutton
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 1, 2023. Always confirm current availability with the study team.