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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: DLTs will be identified from the two first treatment cycles (28 days, a cycle is 14 days)

Primary Outcome 2 - Measure: Adverse events (AEs)

Primary Outcome 2 - Timeframe: Throughout and at the end of trial (up to 24 months after first treatment cycle (a treatment cycle is 14 days))

CONDITION

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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Ruth Plummer, Professor

Role: Principal Investigator

Affiliation: Newcastle Hospitals NHS Foundation Trust

Overall Contact

Name: Ruth Plummer, Professor

Phone: +45 70202728

Email: clinicaltrials@genmab.com

LOCATION