RecruitingPhase 1 / Phase 2

A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two experimental drugs, BNT323 and BNT327, together for advanced breast cancer. It aims to find the best dose of BNT323 and learn how safe and helpful the treatment is. It includes several breast cancer types, including triple-negative breast cancer.

This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have breast cancer confirmed by a tissue test that has grown into nearby areas, cannot be removed by surgery, or has spread to other parts of the body.
  • Have lab results confirming your cancer’s HER2 status. HER2 is a protein that can help cancer cells grow.
  • Have records showing that your cancer fits one of the study groups: HER2-positive, HER2-low, HER2-ultralow, HER2-null, or triple-negative.
  • Have cancer that can be measured using the study’s rules.
  • Have a heart scan within 28 days before joining or being assigned treatment showing that your heart pumps out at least 55% of the blood in its main pumping chamber with each beat.

Who can't join

  • Had a blockage in the small intestine that required a hospital stay within 3 months before the first study dose.
  • Have an uncontrolled illness that would make study rules hard to follow or greatly raise the risk of side effects.
  • Have uncontrolled fluid buildup around the lungs or heart, or in the belly, needing drainage or certain other fluid-removal treatments within 2 weeks before joining or being assigned treatment.
  • Have lung inflammation or scarring called ILD or pneumonitis, previously needed steroids for a noninfectious form of it, or have possible signs that screening scans cannot rule out.
  • Previously received a topoisomerase I inhibitor, a type of cancer drug, including drugs that deliver it directly to cancer cells, such as trastuzumab deruxtecan.
  • Previously received BNT323 or an antibody drug that targets both PD-L1 and VEGF. Prior PD-1/VEGF drugs, PD-1/PD-L1 blockers, and anti-VEGF treatments are allowed.
  • Recently received medicines that boost or weaken the immune system. The waiting period is at least 4 weeks and may be longer depending on the drug. Some locally used steroids and short steroid courses are allowed.
  • Received steroids that affect the whole body at more than 10 mg of prednisone daily, or an equal dose of another steroid, within 3 weeks before study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Have pathologically documented BC that: * Is locally advanced, unresectable or metastatic. * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample. * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines. * Have measurable disease defined by RECIST v1.1. * Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment. Key Exclusion Criteria: * Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP. * Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events. * Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment. * Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan. * Have received any of the following therapies or drugs prior to the initiation of the study: * Participants who have received prior treatment with BNT323. * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) / vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors or anti-VEGF therapies are permitted. * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens). * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Study sites (28)

CA

FL

GA

IL

MI

MO

NJ

NY

TN

TX