Active, currently enrolling
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
NCT No.: NCT06449209
Study Type: Clinical Trial
Phase:
Phase II
Official 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
Purpose
The purpose of the study is to look at how safe and well tolerated the study drug (BNT327) is combination with chemotherapy is and whether it helps to shrink the tumor or to prevent triple negative breast cancer from getting worse.
Detailed Description
Eligibility Criteria
Inclusion Criteria
- 1 Have given informed consent by signing and dating the ICF before initiation ofany trial-specific procedures.
2 Male or female, =18 years of age at the time of giving informed consent.
3 Are willing and able to comply with scheduled visits, the treatment schedule, the planned trial assessments (including participant completed diaries) and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.
4 Have confirmed locally recurrent inoperable or mTNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / CAP guidelines(Wolff et al. 2023). Note, participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer must have histological confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
5 Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable
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- participants with only one target lesion are not eligible to provide a biopsy). The participants most recent formalin-fixed paraffin-embedded (FFPE) tumor sample should be provided (up to a maximum of 24 months prior to the start of the trial
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- unstained sections, 3–5 µm or tissue block). Please see the Laboratory Manual for tissue sampling and processing requirements. If an archival tumor sample is not available, the participant must undergo a fresh biopsy, if medically feasible to be eligible for the trial.
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Exclusion Criteria
- 1 Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 60 days or five half-lives if known (whichever is longer) after the last dose of IMP.
2 Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements.
3 Have histories of alcoholic abuse, psychotropic drug abuse, or illicit drug addiction.
4 Have received any of the following therapies or drugs prior to the
initiation of trial: see clinicaltrials.gov
5 Have undergone major organ surgery (core needle biopsies are allowed >7 days prior trial start), significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.
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Keywords and/or Specific Medical Conditions
Sponsors
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