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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)

28. september 2026 oppdatert av: Sichuan Baili Pharmaceutical Co., Ltd.

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)

This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

436

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina
        • Rekruttering
        • Fudan University Shanghai Cancer Center
        • Ta kontakt med:
          • Jiong Wu
        • Hovedetterforsker:
          • Jian Zhang
        • Hovedetterforsker:
          • Jiong Wu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
  2. Female patients aged 18 to 75 years;
  3. Expected survival time ≥ 3 months;
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  5. Pathologically confirmed recurrent or metastatic triple-negative breast cancer;
  6. Confirmed PD-L1 expression positivity by central laboratory testing;
  7. No prior systemic anti-tumor therapy in the advanced/recurrent or metastatic setting;
  8. Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;
  9. Must have at least one measurable lesion as defined by RECIST v1.1;
  10. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
  11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
  12. Organ function levels must meet the protocol-specified requirements;
  13. Urine protein ≤ 1+ or < 1000 mg/24 h;
  14. For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.

Exclusion Criteria:

  1. Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;
  2. Prior exposure to ADC drugs with topoisomerase I inhibitor payload;
  3. Prior treatment with other T-cell receptor-targeting agents (excluding PD-1/PD-L1);
  4. Use of immunomodulators within 14 days before the first study drug dose;
  5. History of severe cardiac or cerebrovascular disease;
  6. Receiving chronic systemic corticosteroids at >10 mg/day prednisone before the first dose;
  7. Active autoimmune or inflammatory disease;
  8. Any thrombotic event within 6 months before randomization;
  9. Prolonged QTc, complete left bundle branch block, or similar;
  10. Active malignancy diagnosed within 3 years before randomization;
  11. Hypertension uncontrolled by two antihypertensives;
  12. Poorly controlled diabetes/hyperglycemia;
  13. History of steroid-treated ILD/interstitial pneumonitis;
  14. Concurrent lung disease causing clinically significant respiratory impairment;
  15. Active CNS metastases;
  16. Severe infection within 4 weeks before randomization;
  17. Massive or symptomatic serosal effusion;
  18. Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;
  19. Clinically significant bleeding or bleeding tendency within 4 weeks before consent;
  20. Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;
  21. Allergy or contraindication to the study drug;
  22. History of autologous/allogeneic stem cell transplantation;
  23. HIV antibody positive, active HBV, or active HCV;
  24. History of severe neurological or psychiatric illness;
  25. Received or planning to receive live vaccine within 28 days before randomization;
  26. Other conditions rendering the patient unsuitable per investigator's judgment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: BL-B01D1+PD-1 monoclonal antibody

Participants receive BL-B01D1+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Legemiddel: BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

Andre navn:
  • BMS-986507
  • Iza-Bren
  • Izalontamab Brengitecan
Legemiddel: PD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.
Aktiv komparator: nab-paclitaxel+PD-1 monoclonal antibody

Participants receive nab-paclitaxel+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Legemiddel: PD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.

Legemiddel: Nab-paclitaxel

Administration by intravenous infusion for a cycle of 3 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
BICR-assessed Progression-free Survival (PFS)
Tidsramme: Up to approximately 24 months

Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Up to approximately 24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Up to approximately 24 months

Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Up to approximately 24 months
Investigator-assessed Progression-free Survival (PFS)
Tidsramme: Up to approximately 24 months

Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.
Up to approximately 24 months
Objective Response Rate (ORR)
Tidsramme: Up to approximately 24 months

Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Up to approximately 24 months
Disease Control Rate (DCR)
Tidsramme: Up to approximately 24 months

Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Up to approximately 24 months
Duration of Response (DOR)
Tidsramme: Up to approximately 24 months

Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Up to approximately 24 months
Time to Response (TTR)
Tidsramme: Up to approximately 24 months

Time to Response (TTR) is defined as the time from randomization to the first documented response (CR or PR) according to RECIST v1.1 criteria.
Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Tidsramme: Up to approximately 24 months

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
Up to approximately 24 months
Cmax
Tidsramme: Up to approximately 24 months

Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.
Up to approximately 24 months
Tmax
Tidsramme: Up to approximately 24 months

Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.
Up to approximately 24 months
T1/2
Tidsramme: Up to approximately 24 months

Half-life (T1/2) of BL-B01D1 will be investigated.
Up to approximately 24 months
AUC0-t
Tidsramme: Up to approximately 24 months

AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Up to approximately 24 months
CL (Clearance)
Tidsramme: Up to approximately 24 months

CL in the serum of BL-B01D1 per unit of time will be investigated.
Up to approximately 24 months
Ctrough
Tidsramme: Up to approximately 24 months

Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.
Up to approximately 24 months
Anti-drug Antibody (ADA)
Tidsramme: Up to approximately 24 months

Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Up to approximately 24 months
Neutralizing Antibody(NAb)
Tidsramme: Up to approximately 24 months

Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.
Up to approximately 24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Samarbeidspartnere

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. september 2026

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

22. juli 2026

Først lagt ut (Faktiske)

28. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BL-B01D1-325

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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