A Study of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma

NCT07797881 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-220
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II study is a clinical trial exploring the efficacy and safety of BL-B01D1 with or without PD-1 monoclonal antibody in patients with high-risk locally advanced nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate(CRR)

  Post-induction therapy complete response rate will be investigated.

  Up to approximately 24 months

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to approximately 24 months

• Event-free Survival(EFS)

  Up to approximately 24 months

• Distant Metastasis-free Survival(DMFS)

  Up to approximately 24 months

• Locoregional Recurrence-free Survival(LRRFS)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (3)

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

BL-B01D1

EXPERIMENTAL

Participants receive BL-B01D1 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

Gemcitabine + Cisplatin

ACTIVE COMPARATOR

Participants receive Gemcitabine + Cisplatin 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: Gemcitabine; Drug: Cisplatin

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; 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

Gemcitabine DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Gemcitabine + Cisplatin

Cisplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Gemcitabine + Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No gender restriction;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Pathologically confirmed as newly diagnosed nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
• Patients with locally regionally advanced nasopharyngeal carcinoma(Stage T4N1M0 or T1-4N2-3M0(AJCC/UICC 9th edition));
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 1 year, or fresh tissue samples;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥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 the start of treatment; serum pregnancy test must exclude pregnancy, and patients must be non-lactating; all enrolled trial participants (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the completion of treatment.

You may not qualify if:

• Prior receipt of any anti-tumor systemic therapy regimen for nasopharyngeal carcinoma；
• Use of modern traditional Chinese medicine preparations that have been approved by the NMPA for anti-tumor therapy within 2 weeks prior to the first dose；
• History of severe cardiac or cerebrovascular disease；
• Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias；
• Active autoimmune diseases and inflammatory diseases；
• 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/interstitial pneumonia requiring corticosteroid therapy, etc.；
• Concurrent pulmonary disease resulting in severe impairment of respiratory function；
• Trial participants with massive serous cavity effusion, or symptomatic serous cavity effusion, or serous cavity effusion that is poorly controlled；
• Imaging findings indicating tumor invasion or encasement of major blood vessels in the neck, pharynx, or other regions；
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening；
• Trial participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-B01D1；
• Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation；

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; Gemcitabine; Cisplatin

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86 15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

CN (1)