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Pumitamig plus chemotherapy for metastatic triple-negative breast cancer

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

Phase 3 Interventional BioNTech SE · NCT07173751

This trial will test whether adding pumitamig to standard chemotherapy helps people with metastatic or inoperable triple-negative breast cancer who are not eligible for PD(L)1 combo therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment558 (estimated)
Ages18 Years and up
SexAll
SponsorBioNTech SE Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations83 sites (Springdale, Arkansas and 82 other locations)
Trial IDNCT07173751 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind Phase 3 trial that assigns participants 1:1 to receive either pumitamig plus physician's choice chemotherapy or placebo plus the same chemotherapy. Chemotherapy options include paclitaxel/nab-paclitaxel, gemcitabine plus carboplatin, or eribulin and are given per standard of care until disease progression or unacceptable toxicity. Randomization is stratified by prior immunotherapy exposure, chosen chemotherapy regimen, geography (East Asia vs rest of world), and PD‑L1 combined positive score. Participants undergo screening, an on-treatment period, a 90-day safety follow-up after last dose, and long-term survival follow-up.

Who should consider this trial

Good fit: Adults with confirmed locally recurrent inoperable or metastatic triple-negative breast cancer (or ER‑low/HER2‑negative disease), at least one measurable lesion, an available tumor tissue sample, and who are considered ineligible for PD(L)1 plus chemotherapy are the intended participants.

Not a fit: Patients whose tumors make them eligible for standard PD(L)1 plus chemotherapy, those with only one target lesion, or those unable to provide acceptable tissue samples are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could improve tumor control or extend survival for patients with metastatic TNBC who cannot receive PD(L)1-based combination therapy.

How similar studies have performed: PD(L)1 inhibitors combined with chemotherapy have shown benefit in PD‑L1–positive TNBC, but bispecific antibodies like pumitamig represent a newer approach with limited phase 3 experience to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor \[PgR\]) 1% to 10%, HER2 immunohistochemistry \[IHC\] 0, 1+, or 2+ with fluorescence in situ hybridization \[FISH\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
* 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; participants with only one target lesion are not eligible to participate in the trial).
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Have received any of the following therapies or drugs prior to the initiation of trial:

  * Have received prior systemic anticancer therapy for advanced disease.
  * Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody.
  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \[mg\]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).
  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.
  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
* Have undergone major organ surgery, 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.
* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Where this trial is running

Springdale, Arkansas and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast NeoplasmsMetastatic TNBCBispecific antibodyProgrammed death-ligand 1ImmunotherapyImmunotherapy in combination with chemotherapyCombination with other investigational agents
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.