A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01)

NCT06118333 | Active Not Recruiting Phase 3

• 1 other identifier: BL-B01D1-303
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

A phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who had failed at least two lines of platinum-based chemotherapy after receiving PD-1/PD-L1 monoclonal antibody as the last line of therapy.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  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

• Overall survival (OS)

  Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

  Up to approximately 24 months

Secondary Outcomes (7)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants receive BL-B01D1 as intravenous infusion 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

Control group

EXPERIMENTAL

Participants receive capecitabine, gemcitabine, docetaxel 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.

Drug: capecitabine; Drug: gemcitabine; Drug: docetaxel

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion

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

Experimental group

capecitabine DRUG

Oral administration

Control group

gemcitabine DRUG

Administration by intravenous infusion

Control group

docetaxel DRUG

Administration by intravenous infusion

Control group

Eligibility Criteria

• Age: 18 Years - 75 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 and ≤75 years;
• Expected survival time ≥3 months;
• Patients with recurrent or metastatic nasopharyngeal carcinoma confirmed by histology or cytology, who have failed treatment with PD-1/PD-L1 monoclonal antibodies and at least two lines of chemotherapy (including at least one platinum-based regimen);
• Patients with recurrent or metastatic nasopharyngeal carcinoma suitable for receiving the control group chemotherapy drugs specified in this protocol as the last-line treatment;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor treatment has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements without transfusion, use of any cell growth factors, and/or platelet-raising drugs within 14 days before randomization;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urine protein ≤2+ or \<1000mg/24h;
• For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative. They must not be breastfeeding. All enrolled patients should take adequate barrier contraception measures throughout the treatment period and for 6 months after treatment ends.

You may not qualify if:

• Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives before randomization, or palliative radiotherapy and antitumor therapy within 2 weeks;
• Patients with recurrent nasopharyngeal carcinoma suitable for curative-intent local treatment (surgery or radiotherapy) should be excluded;
• Prior treatment with ADC drugs containing topoisomerase I inhibitor as the small-molecule toxin, or ADC drugs targeting EGFR and/or HER3;
• History of severe cardiac disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening (except for catheter-related thrombosis lasting \>4 weeks);
• QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Diagnosis of active malignancy within 3 years before randomization;
• Poorly controlled hypertension despite two antihypertensive medications, or poorly controlled diabetes, or presence of diabetic gangrene;
• History of ILD requiring steroid treatment, current ILD, or ≥Grade 2 radiation pneumonitis;
• Concurrent pulmonary disease resulting in clinically significant respiratory impairment;
• Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or vascular structures (if the investigator deems it does not affect patient eligibility, discussion with the sponsor's medical team is required);
• Patients with active central nervous system metastases;
• History of allergy to recombinant humanized antibodies or any excipient of BL-B01D1;
• History of autologous or allogeneic stem cell transplantation;
• Positive for HIV antibody, active HBV infection, or HCV infection;

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

Related Publications (1)

• Yang Y, Zhou H, Tang L, Qiu S, Han Y, Ji D, Chen X, Lei F, Qu S, Deng B, Chen L, Huang J, Guo Y, Liu Z, Chen D, Li J, Shu X, Qin Y, Fu Z, Li B, Zhang P, Chen S, Hong J, Wei Y, Qin X, Qu S, Yang K, Lin D, Wang J, Yang L, Xiao S, Zhu H, Zhu Y, Zhang L; BL-B01D1-303 Investigators. Izalontamab brengitecan, an EGFR and HER3 bispecific antibody-drug conjugate, versus chemotherapy in heavily pretreated recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 study in China. Lancet. 2025 Nov 8;406(10516):2235-2243. doi: 10.1016/S0140-6736(25)01954-3. Epub 2025 Oct 19.

  PMID: 41125110 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Capecitabine; Gemcitabine; Docetaxel

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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Li Zhang, PHD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

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: October 25, 2023
• First Posted: November 7, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)