Nasopharyngeal Carcinoma (NPC)
Conditions
Brief 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 metastatic nasopharyngeal carcinoma.
Interventions
DRUGBL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGPD-1 monoclonal antibody
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGcisplatin
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGgemcitabine
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age ≥ 18 years; 3. Expected survival time ≥ 3 months; 4. Trial participants with nasopharyngeal carcinoma confirmed by histopathology and/or cytology, either initially diagnosed with metastatic disease or relapsed after curative-intent treatment; 5. Agree to provide tumor tissue samples obtained at or after the diagnosis of recurrent or metastatic disease; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; 10. Organ function levels must meet the required criteria; 11. Urine protein ≤ 1+ or \< 1000 mg/24h; 12. 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.
Exclusion criteria
1. Trial participants who have received prior systemic therapy; 2. Those who have received prior therapy targeting the mechanism of tumor immuno-oncology; 3. Those who have previously received antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, or EGFR- and/or HER3-targeting antibodies/ADCs; 4. Trial participants who have received systemic immunostimulatory agents within 4 weeks prior to the first dose; 5. Those who have received radical radiotherapy, major surgery, or extensive-field radiotherapy within 4 weeks prior to study randomization; 6. History of severe cardiac or cerebrovascular disease; 7. Those receiving long-term systemic corticosteroid therapy (e.g., prednisone \>10 mg/day) prior to the first dose; 8. Active autoimmune diseases and inflammatory diseases; 9. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; 10. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 11. Diagnosis of active malignancy within 3 years prior to study randomization; 12. Hypertension inadequately controlled by two antihypertensive agents; 13. Trial participants with poorly controlled blood glucose; 14. History of interstitial lung disease (ILD) requiring steroid therapy, current ILD, or radiation pneumonitis of Grade ≥2; 15. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function; 16. Active central nervous system (CNS) metastases; 17. Severe infection occurring within 4 weeks prior to study randomization; 18. Trial participants with massive serosal cavity effusion, symptomatic serosal cavity effusion, or poorly controlled serosal cavity effusion; 19. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or cervical structures; 20. Severe, non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent; 21. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; 22. Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea; 23. Trial participants with a history of allergy to recombinant humanized antibodies or hypersensitivity to the investigational drug; 24. History of autologous or allogeneic stem cell transplantation; 25. Positive for human immunodeficiency virus (HIV) antibodies, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection; 26. History of severe neurological or psychiatric disorders; 27. Receipt of other unapproved investigational drugs or treatments within 4 weeks prior to study randomization; 28. Trial participants who plan to receive, or have received, live vaccines within 28 days prior to study randomization; 29. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial due to complications or other circumstances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BICR-assessed Progression-free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 24 months | Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death. |
| Investigator-assessed Progression-free Survival (PFS) | Up to approximately 24 months | 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. |
| Treatment Emergent Adverse Event (TEAE) | Up to approximately 24 months | 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. |
| Cmax | Up to approximately 24 months | Cmax is defined as the maximum observed drug concentration in plasma after administration. |
| Tmax | Up to approximately 24 months | Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration. |
| T1/2 | Up to approximately 24 months | T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase. |
| AUC0-t | Up to approximately 24 months | AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration. |
| CL (Clearance) | Up to approximately 24 months | Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time. |
| Ctrough | Up to approximately 24 months | Ctrough is defined as the lowest serum concentration prior to the next dose will be administered. |
| Anti-drug Antibody (ADA) | Up to approximately 24 months | Frequency of anti-BL-B01D1 antibody (ADA) will be investigated. |
| Neutralizing Antibody(NAb) | Up to approximately 24 months | Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed