BNT327-02 - Study of BNT327 for pts with TNBC w/ chemo
Research type
Research Study
Full title
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
IRAS ID
1010046
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
BioNTech SE
Clinicaltrials.gov Identifier
Research summary
The main purpose of this clinical research study is to look at how safe and well tolerated the study drug (called BNT327) in combination with chemotherapy is and whether it helps to prevent triple-negative breast cancer that is either untreated or has grown or spread after first-line therapy. The study drug is designed to block the function of proteins that lower the body's ability to fight infection and disease, to reduce blood vessel growth in a tumour (and thus reduce tumour growth), and reduce or stop tumour growth and spreading.
Approximately 60 participants will be recruited globally.
Following informed consent and after the screening period (lasting up to 21 days), there will be 2 study periods: treatment (lasting up to 2 years) and a follow-up period (lasting up to 1 year). Participants will know which treatment group they are assigned.
The participant will undergo: collection of demographics and medical history, physical examination, vital signs, weight and height, blood tests (for safety and pregnancy testing), urine and stool tests, ECGs, ECHOs, tumour imaging and assessments, archival or fresh tumour tissue testing (if available), performance assessments, questionnaires and tumour status assessments.
The possible risks or discomforts from taking part in this study may include: increased blood pressure, elevated protein in the urine, immune-related side effects, intestinal perforation, bleeding, delayed wound healing, bruising, or infection at the sites of treatment infusion/blood collection.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0178
Date of REC Opinion
23 Jul 2024
REC opinion
Further Information Favourable Opinion