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 | Not Yet Recruiting Phase 3

• 1 other identifier: BL-B01D1-322
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• BICR-assessed Progression-free Survival (PFS)

  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

Secondary Outcomes (11)

• Overall Survival (OS)

  Up to approximately 24 months

• Investigator-assessed Progression-free Survival (PFS)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

• Tmax

  Up to approximately 24 months

Study Arms (2)

BL-B01D1+PD-1 monoclonal antibody

EXPERIMENTAL

Participants receive BL-B01D1+PD-1 monoclonal antibody for 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.

Drug: BL-B01D1; Drug: PD-1 monoclonal antibody

PD-1 monoclonal antibody

ACTIVE COMPARATOR

Participants receive PD-1 monoclonal antibody for 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.

Drug: PD-1 monoclonal antibody

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1+PD-1 monoclonal antibody

PD-1 monoclonal antibody DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1+PD-1 monoclonal antibody; PD-1 monoclonal antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age ≥ 18 years;
• Expected survival time ≥ 3 months;
• Trial participants with nasopharyngeal carcinoma confirmed by histopathology and/or cytology, either initially diagnosed with metastatic disease or relapsed after curative-intent treatment;
• Agree to provide tumor tissue samples obtained at or after the diagnosis of recurrent or metastatic disease;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
• Organ function levels must meet the required criteria;
• Urine protein ≤ 1+ or \< 1000 mg/24h;
• 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.

You may not qualify if:

• Trial participants who have received prior systemic therapy;
• Those who have received prior therapy targeting the mechanism of tumor immuno-oncology;
• Those who have previously received antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, or EGFR- and/or HER3-targeting antibodies/ADCs;
• Trial participants who have received systemic immunostimulatory agents within 4 weeks prior to the first dose;
• Those who have received radical radiotherapy, major surgery, or extensive-field radiotherapy within 4 weeks prior to study randomization;
• History of severe cardiac or cerebrovascular disease;
• Those receiving long-term systemic corticosteroid therapy (e.g., prednisone \>10 mg/day) prior to the first dose;
• Active autoimmune diseases and inflammatory diseases;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
• Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Diagnosis of active malignancy within 3 years prior to study randomization;
• Hypertension inadequately controlled by two antihypertensive agents;
• Trial participants with poorly controlled blood glucose;
• History of interstitial lung disease (ILD) requiring steroid therapy, current ILD, or radiation pneumonitis of Grade ≥2;
• Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)