BNT 372-02: A Phase II, multi-site, randomized, open-label clinical trial to evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with chemotherapeutic agents as first- and second line treatment in triple-negative breast cancer
Principal Investigator: Jayanthi Vijayakumar, MD
Study Sponsor: BioNTech SE
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: This study is looking to test the safety and effectiveness of study drug BNT327 (also called PM8002) in triple-negative breast cancer. The study drug is a bi-specific antibody, which means that the study drug consists of an antibody that specifically binds to two different target proteins. Antibodies are protective proteins produced by your immune system. The two target proteins are programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A). By blocking the function of these proteins, study drug could increase your body’s ability to fight infection and disease, reduce the blood supply in your tumor (and thus reduce tumor growth), and reduce or stop tumor spreading.
Inclusion Criteria:
– Must be at least 18 or older.
– Must provide fresh or archival tumor sample during screening period.
– Must have at least 1 measurable lesion per RECIST 1.1
– ECOG of 0-1
– Minimum life expectancy of more than 3 months.
– Must have adequate organ function per local lab tests.
– Must practice highly effective methods of contraception while on study and for 6 months after the last dose of study drug.
– Women of childbearing potential must not donate eggs until after 6 months after last dose. Men must agree not to donate sperm for the same.
Additional criteria may apply and will be discussed with the treating physician and study team.
Exclusion Criteria:
– Pregnant or breastfeeding or if planning to have children during trial or within 60 days after the last dose.
– Has medical, psychological or social condition that, in the opinion of the investigator would impact the patient’s ability to adhere to protocol and visit requirements.
– History of alcoholic abuse, psychotropic drug abuse, or illicit drug addiction.
– Have received any of the following therapies or drugs prior to initial treatment: prior treatment with PDL1/VEGF bispecific antibody.
– Received systemic anti-cancer therapy within 4-weeks prior to starting study drug, or has received palliative radiotherapy within 7 days prior to starting study.
– Received systemic immunosuppressive therapies within 5 weeks prior to starting study drug. Exceptions are local, intranasal, intra-ocular, intra-articular, or inhaled corticosteroids, short-term use (less than 7 days).
– Received systemic corticosteroids (dosage greater than 10mg/day of prednisone or equivalent) within 3 weeks prior to initiation of trial treatment.
– Live or attenuated vaccine within 4 weeks
– Received IV antibiotics within 3 weeks prior to study start.
– Use of any other investigational product within 4 weeks prior to starting study treatment, or is taking part in another investigational interventional clinical trial.
– Major organ surgery, significant trauma, invasive dental procedures within 28 days prior to study start.
– Received allogenic stem cell transplant or organ transplant.
– Brain mets (with certain exceptions, to be discussed with study team and physician).
– Autoimmune disease requiring systemic treatment.
– Other malignant tumors within 5 years prior to trial treatment.
– Significant heart conditions within 6 months prior to study start.
– Hypertension or diabetic condition prior to initiation of trial treatment.
– Serious non-healing wounds, ulcers, or bone fractures.
– Evidence of major coagulation disorders or other significant risks of hemorrhage such as intracranial or intraspinal hemorrhage, tumor lesions invading large blood vessels with risk of bleeding, thrombosis or embolism within 6 months prior to initiation of treatment, clinically significant hemoptysis or tumor hemorrhage within 1 month prior to initiation of trial treatment, anticoagulant therapy for therapeutic purposes within 14 days prior to study start, received anti-platelet drugs within 10 days prior to study start.
– Uncontrolled pleural, pericardial effusion, or ascites requiring recurrent draining.
– Hypersensitivity to trial treatment or active ingredients
– Has HIV or AIDS
– Know active or history of Hepatitis B or C must have viral load below the limit of quantification.
– Has superior vena cava syndrome or spinal cord compression.
– Have TB or history of TB not successfully treated
Additional criteria may apply and will be discussed with the treating physician and study team.
Study Contact:
Alissa Gavenda, RN, OCN
(952) 993-6705
alissa.gavenda@parknicollet.com
