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Nasopharyngeal CarcinomaPhase 3NCT06118333

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

A Phase 3 study testing BL-B01D1, capecitabine and gemcitabine in people with Nasopharyngeal Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
BL-B01D1, capecitabine and gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
1 siteChina
Study dates
4 Dec 2023to Nov 2026
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 to 75 years
  • 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 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Severe infection within 4 weeks before randomization, or pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
  • Pleural effusion, pericardial effusion, or ascites requiring drainage and/or symptomatic within 4 weeks before randomization;
  • Use of other investigational drugs or therapies within 4 weeks before randomization;
  • History of severe neurological or psychiatric disorders;
  • Presence of severe unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent;
  • Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;
  • History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea;
  • Subjects planning to receive or having received live vaccines within 28 days before randomization;
  • Any other condition deemed by the investigator to make the patient unsuitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)

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.

Read the detailed description

Primary objective: To evaluate BICR-based objective response rate (ORR) and overall survival (OS) benefit of BL-B01D1 versus physician's choice of chemotherapy.

Being tested
BL-B01D1, capecitabine, gemcitabine, docetaxel
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

  • capecitabineDrug

    Oral administration

  • gemcitabineDrug

    Administration by intravenous infusion

  • docetaxelDrug

    Administration by intravenous infusion

Study groups in NCT06118333
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants 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.
Receives: Drug: BL-B01D1
Control groupExperimentalParticipants 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.
Receives: Drug: capecitabine; Drug: gemcitabine; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 24 months

  2. Overall survival (OS)

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

    Measured: Up to approximately 24 months

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by BIRC was 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

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

  4. 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

  5. Cmax

    Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  6. T1/2

    Half-life (T1/2) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  7. Anti-drug antibody (ADA)

    Frequency of anti-BL-B01D1 antibody (ADA) 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.

  1. First posted7 Nov 2023
  2. Study start4 Dec 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118333
Sponsor's protocol ID
BL-B01D1-303
Status last verified
Apr 2026
First submitted
25 Oct 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41125110

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-B01D1, capecitabine and gemcitabine in people with Nasopharyngeal Carcinoma, 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 13 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118333, which also lists 1 linked publication.

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 17 Apr 2026.

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