# A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inopera

Source: https://onco.cc/trials/nct07729956/  
OnCo record `nct07729956` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of izalontamab brengitecan and nab-paclitaxel in triple-negative breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., not yet recruiting.

## Summary

A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04) is a phase 3, randomised interventional study registered as NCT07729956 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 436 participants, started 2026-08 and due to reach its primary completion in 2029-12. Interventions recorded: BL-B01D1; PD-1 monoclonal antibody; Nab-paclitaxel. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: "Pathologically confirmed recurrent or metastatic triple-negative breast cancer;". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; tnbc-deep-dive
- Registry id: NCT07729956
- Phase: 3
- Setting: A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
- Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
- Enrolled: 436

## Sources

- ClinicalTrials.gov NCT07729956: https://clinicaltrials.gov/study/NCT07729956

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Izalontamab brengitecan](https://onco.cc/drugs/izalontamab-brengitecan/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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