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Clinical Trials in China / NCT07783321
Starting soon Phase 3

A Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)

NCT07783321 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2026-09
Last updated
2026-09-15

Condition(s) studied

Nasopharyngeal Carcinoma (NPC)

Investigational drug(s) / intervention(s)

BL-B01D1PD-1 monoclonal antibodycisplatingemcitabine

BL-B01D1: Administration by intravenous infusion for a cycle of 3 weeks.

PD-1 monoclonal antibody: Administration by intravenous infusion for a cycle of 3 weeks.

cisplatin: Administration by intravenous infusion for a cycle of 3 weeks.

gemcitabine: Administration by intravenous infusion for a cycle of 3 weeks.

Study summary

This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with chemotherapy, followed by maintenance therapy with PD-1 monoclonal antibody with or without BL-B01D1, as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age ≥ 18 years; 3. Expected survival time ≥ 3 months; 4. Trial participants with nasopharyngeal carcinoma confirmed by histopathology and/or cytology, either initially diagnosed with metastatic disease or relapsed after curative-intent treatment; 5. Agree to provide tumor tissue samples obtained at or after the diagnosis of recurrent or metastatic disease; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; 10. Organ function levels must meet the required criteria; 11. Urine protein ≤ 1+ or \< 1000 mg/24h; 12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must rule out pregnancy; they must not be breastfeeding and must use highly effective contraceptive methods throughout the entire treatment period and for 7 months after the last dose. For male trial participants whose partners are women of childbearing potential, adequate barrier contraception must be used throughout the entire treatment period and for 7 months after the end of treatment. Exclusion Criteria: 1. Trial participants who have received prior systemic therapy; 2. Those who have received prior therapy targeting the mechanism of tumor immuno-oncology; 3. Those who have previously received antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, or EGFR- and/or HER3-targeting antibodies/ADCs; 4. Trial participants who have received systemic immunostimulatory agents within 4 weeks prior to the first dose; 5. Those who have received radical radiotherapy, major surgery, or extensive-field radiotherapy within 4 weeks prior to study randomization; 6. History of severe cardiac or cerebrovascular disease; 7. Those receiving long-term systemic corticosteroid therapy (e.g., prednisone \>10 mg/day) prior to the first dose; 8. Active autoimmune diseases and inflammatory diseases; 9. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; 10. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 11. Diagnosis of active malignancy within 3 years prior to study randomization; 12. Hypertension inadequately controlled by two antihypertensive agents; 13. Trial participants with poorly controlled blood glucose; 14. History of interstitial lung disease (ILD) requiring steroid therapy, current ILD, or radiation pneumonitis of Grade ≥2; 15. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function; 16. Active central nervous system (CNS) metastases; 17. Severe infection occurring within 4 weeks prior to study randomization; 18. Trial participants with massive serosal cavity effusion, symptomatic serosal cavity effusion, or poorly controlled serosal cavity effusion; 19. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or cervical structures; 20. Severe, non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent; 21. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; 22. Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea; 23. Trial participants with a history of allergy to recombinant humanized antibodies or hypersensitivity to the investigational drug; 24. History of autologous or allogeneic stem cell transplantation; 25. Positive for human immunodeficiency virus (HIV) antibodies, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection; 26. History of severe neurological or psychiatric disorders; 27. Receipt of other unapproved investigational drugs or treatments within 4 weeks prior to study randomization; 28. Trial participants who plan to receive, or have received, live vaccines within 28 days prior to study randomization; 29. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial due to complications or other circumstances.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

More Sichuan Baili Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783321 on ClinicalTrials.gov ↗ ← All trials in China