Nasopharyngeal Carcinoma (NPC)
Conditions
Brief 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.
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.
DRUGGemcitabine
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGCisplatin
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 75 Years
Healthy volunteers
No
Inclusion criteria
1. No gender restriction; 2. Age: ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. Pathologically confirmed as newly diagnosed nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)"; 5. Patients with locally regionally advanced nasopharyngeal carcinoma(Stage T4N1M0 or T1-4N2-3M0(AJCC/UICC 9th edition)); 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 1 year, or fresh tissue samples; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥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 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.
Exclusion criteria
1. Prior receipt of any anti-tumor systemic therapy regimen for nasopharyngeal carcinoma； 2. 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； 3. History of severe cardiac or cerebrovascular disease； 4. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias； 5. Active autoimmune diseases and inflammatory diseases； 6. Diagnosis of active malignancy within 3 years prior to study randomization； 7. Hypertension inadequately controlled by two antihypertensive agents； 8. Trial participants with poorly controlled blood glucose； 9. History of interstitial lung disease/interstitial pneumonia requiring corticosteroid therapy, etc.； 10. Concurrent pulmonary disease resulting in severe impairment of respiratory function； 11. Trial participants with massive serous cavity effusion, or symptomatic serous cavity effusion, or serous cavity effusion that is poorly controlled； 12. Imaging findings indicating tumor invasion or encasement of major blood vessels in the neck, pharynx, or other regions； 13. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening； 14. 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； 15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation； 16. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection； 17. Severe infection occurring within 4 weeks prior to the first use of the investigational drug； 18. History of psychotropic substance abuse that cannot be abstained from, or history of severe neurological or psychiatric disorders； 19. Severe and unhealed wounds, ulcers, or fractures within 4 weeks prior to signing informed consent； 20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first dose of the investigational drug； 21. Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.； 22. Trial participants who plan to receive or have received live vaccines within 28 days prior to study randomization； 23. Other conditions that, in the investigator's judgment, make the participant unsuitable for participation in this clinical trial due to complications or other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate(CRR) | Up to approximately 24 months | Post-induction therapy complete response rate will be investigated. |
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. |
| Event-free Survival(EFS) | Up to approximately 24 months | Event-free Survival will be investigated. |
| Distant Metastasis-free Survival(DMFS) | Up to approximately 24 months | Distant Metastasis-free Survival will be investigated. |
| Locoregional Recurrence-free Survival(LRRFS) | Up to approximately 24 months | Locoregional Recurrence-free Survival will be investigated. |
| 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. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed