Nasopharyngeal Carcinoma (NPC)Phase 3NCT07783321
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)
A Phase 3 study testing BL-B01D1, PD-1 monoclonal antibody and cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- BL-B01D1, PD-1 monoclonal antibody and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Active central nervous system (CNS) metastases;
- Severe infection occurring within 4 weeks prior to study randomization;
- Trial participants with massive serosal cavity effusion, symptomatic serosal cavity effusion, or poorly controlled serosal cavity effusion;
- Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or cervical structures;
- Severe, non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent;
- Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
- Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea;
- Trial participants with a history of allergy to recombinant humanized antibodies or hypersensitivity to the investigational drug;
- History of autologous or allogeneic stem cell transplantation;
- Positive for human immunodeficiency virus (HIV) antibodies, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;
- History of severe neurological or psychiatric disorders;
- Receipt of other unapproved investigational drugs or treatments within 4 weeks prior to study randomization;
- Trial participants who plan to receive, or have received, live vaccines within 28 days prior to study randomization;
- Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial due to complications or other circumstances.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang
Li Zhang
About this study
Official title: A Phase III Randomized Controlled Clinical 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)
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)
- Being tested
- BL-B01D1, PD-1 monoclonal antibody, cisplatin, gemcitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
Administration by intravenous infusion for a cycle of 3 weeks.
PD-1 monoclonal antibodyDrug
Administration by intravenous infusion for a cycle of 3 weeks.
cisplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
gemcitabineDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1+PD-1 monoclonal antibody | Experimental | During the induction treatment phase, participants will receive PD-1 monoclonal antibody, cisplatin or gemcitabine. During the maintenance treatment phase: participants will 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. Receives: Drug: BL-B01D1; Drug: PD-1 monoclonal antibody; Drug: cisplatin; Drug: gemcitabine |
| PD-1 monoclonal antibody | Active comparator | During the induction treatment phase, participants will receive PD-1 monoclonal antibody, cisplatin or gemcitabine. During the maintenance treatment phase: participants will 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. Receives: Drug: PD-1 monoclonal antibody; Drug: cisplatin; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 24 months
Secondary outcomes (11)
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Measured: Up to approximately 24 months
Investigator-assessed Progression-free Survival (PFS)
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.
Measured: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
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.
Measured: Up to approximately 24 months
Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
Measured: Up to approximately 24 months
Tmax
Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.
Measured: Up to approximately 24 months
T1/2
T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.
Measured: Up to approximately 24 months
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to approximately 24 months
CL (Clearance)
Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.
Measured: Up to approximately 24 months
Anti-drug Antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Neutralizing Antibody(NAb)
Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783321
- Sponsor's protocol ID
- BL-B01D1-322
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Clinical 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)
- ClinicalTrials.gov ID
- NCT07783321
- Acronym / sponsor ID
- BL-B01D1-322
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1+PD-1 monoclonal antibody | Experimental | Drug: BL-B01D1, Drug: PD-1 monoclonal antibody, Drug: cisplatin, Drug: gemcitabineDuring the induction treatment phase, participants will receive PD-1 monoclonal antibody, cisplatin or gemcitabine. During the maintenance treatment phase: participants will 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. |
| PD-1 monoclonal antibody | Active comparator | Drug: PD-1 monoclonal antibody, Drug: cisplatin, Drug: gemcitabineDuring the induction treatment phase, participants will receive PD-1 monoclonal antibody, cisplatin or gemcitabine. During the maintenance treatment phase: participants will 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1+PD-1 monoclonal antibody |
| PD-1 monoclonal antibodyAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1+PD-1 monoclonal antibody, PD-1 monoclonal antibody |
| cisplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1+PD-1 monoclonal antibody, PD-1 monoclonal antibody |
| gemcitabineAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1+PD-1 monoclonal antibody, PD-1 monoclonal antibody |
Primary outcome
BICR-assessed Progression-free Survival (PFS)
Time frame: 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.
11 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 24 months
Investigator-assessed Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to approximately 24 months
Tmax
Time frame: Up to approximately 24 months
T1/2
Time frame: Up to approximately 24 months
AUC0-t
Time frame: Up to approximately 24 months
CL (Clearance)
Time frame: Up to approximately 24 months
Ctrough
Time frame: Up to approximately 24 months
Anti-drug Antibody (ADA)
Time frame: Up to approximately 24 months
Neutralizing Antibody(NAb)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-B01D1, PD-1 monoclonal antibody and cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sa Xiao, PHD (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BICR-assessed Progression-free Survival (PFS) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.