Nasopharyngeal Carcinoma (NPC)Phase 2NCT07797881
A Study of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing BL-B01D1, PD-1 monoclonal antibody and Gemcitabine in people with Nasopharyngeal Carcinoma (NPC), run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- BL-B01D1, PD-1 monoclonal antibody and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2030
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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；
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- 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；
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection；
- Severe infection occurring within 4 weeks prior to the first use of the investigational drug；
- History of psychotropic substance abuse that cannot be abstained from, or history of severe neurological or psychiatric disorders；
- Severe and unhealed wounds, ulcers, or fractures within 4 weeks prior to signing informed consent；
- Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first dose of the investigational drug；
- Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.；
- Trial participants who plan to receive or have received live vaccines within 28 days prior to study randomization；
- Other conditions that, in the investigator's judgment, make the participant unsuitable for participation in this clinical trial due to complications or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma
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)
- Being tested
- BL-B01D1, PD-1 monoclonal antibody, Gemcitabine, Cisplatin
- 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.
GemcitabineDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CisplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate(CRR)
Post-induction therapy complete response rate will be investigated.
Measured: Up to approximately 24 months
Secondary outcomes (5)
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
Event-free Survival(EFS)
Event-free Survival will be investigated.
Measured: Up to approximately 24 months
Distant Metastasis-free Survival(DMFS)
Distant Metastasis-free Survival will be investigated.
Measured: Up to approximately 24 months
Locoregional Recurrence-free Survival(LRRFS)
Locoregional Recurrence-free Survival will be investigated.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07797881
- Sponsor's protocol ID
- BL-B01D1-220
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 16 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07797881
- Acronym / sponsor ID
- BL-B01D1-220
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 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 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Sep 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1+PD-1 monoclonal antibody | Experimental | Drug: BL-B01D1, Drug: PD-1 monoclonal antibodyParticipants 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. |
| BL-B01D1 | Experimental | Drug: BL-B01D1Participants 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. |
| Gemcitabine + Cisplatin | Active comparator | Drug: Gemcitabine, Drug: CisplatinParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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));
Key exclusion criteria (23 listed)
- 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；
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, 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 |
| GemcitabineAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Gemcitabine + Cisplatin |
| CisplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Gemcitabine + Cisplatin |
Primary outcome
Complete Response Rate(CRR)
Time frame: Up to approximately 24 months
Post-induction therapy complete response rate will be investigated.
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 24 months
Event-free Survival(EFS)
Time frame: Up to approximately 24 months
Distant Metastasis-free Survival(DMFS)
Time frame: Up to approximately 24 months
Locoregional Recurrence-free Survival(LRRFS)
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
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 16 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 2 study testing BL-B01D1, PD-1 monoclonal antibody and Gemcitabine 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 23 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 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (+86 15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate(CRR) (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 16 Sep 2026.