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

  • STATUS
    Recruiting
  • End date
    Mar 24, 2022
  • participants needed
    520
  • sponsor
    Genmab
Updated on 24 July 2021
renal function
cancer
measurable disease
metastasis
solid tumour
metastatic cancer
renal function tests
renal function test
kidney function test

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

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.

Details
Condition Pancreatic Cancer, Non-Small Cell Lung Cancer, Adenocarcinoma, Colorectal Cancer, Malignant neoplasm of kidney, Rectal disorder, Pancreatic disorder, Breast Cancer, Renal Cell Carcinoma, Neoplasm of unspecified nature of digestive system, Gastropathy, Gastric Cancer, Diet and Nutrition, Chronic Diarrhea, Stomach Discomfort, Pancreatic Disorders, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Urothelial Cancer, Gastric Carcinoma, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Islet Ce417ll Cancer, Metastatic Triple-Negative Breast Cancer, Kidney Cancer, Malignant Adenoma, Stomach Cancer, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, clear cell renal cell carcinoma, colorectal neoplasm, gastric cancers, colorectal cancers, nsclc, cancer of the pancreas, pancreatic cancers, cancer, pancreatic, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment GEN1029 (HexaBody®-DR5/DR5)
Clinical Study IdentifierNCT03576131
SponsorGenmab
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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