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Trial Title:
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
NCT ID:
NCT06437522
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
PD-1 monoclonal antibody
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Summary:
This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 +
PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic
head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject volunteered to participate in the study and signed an informed consent;
2. Male or female aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0-1;
5. Patients with recurrent or metastatic head and neck squamous cell carcinoma
(non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology
and/or cytology;
6. Patients must provide a documented tumor tissue specimen of the primary or
metastatic tumor within 3 years for PD-L1 testing and other testing;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs
within 14 days before screening, and the organ function level must meet the
requirements;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
10. For premenopausal women of childbearing potential, a pregnancy test must be
performed within 7 days before the initiation of treatment, a serum or urine
pregnancy test must be negative, and the patient must not be lactating; All enrolled
patients should take adequate barrier contraception during the entire treatment
cycle and for 6 months after the end of treatment.
Exclusion Criteria:
1. Prior treatment with an ADC drug with TOP I inhibitors as a toxin;
2. Before the first delivery within four weeks or five half-life used anti-tumor
treatment; Palliative radiotherapy was given within 2 weeks before the first dose;
3. Received any previous systemic antitumor regimen for solid tumors such as recurrent
or metastatic head and neck squamous cell carcinoma;
4. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related
myocarditis;
5. Use of an immunomodulatory drug within 14 days before the first dose of study drug;
6. Systemic corticosteroids were required within 2 weeks before the first dose of the
study;
7. Has a history of severe disease of heart head blood-vessel;
8. Active autoimmune and inflammatory diseases;
9. Other malignant tumors that progressed or required treatment within 3 years before
the first dose;
10. With ILD requiring steroid treatment, current ILD, or suspected ILD at screening;
11. Presence of: a) poorly controlled diabetes mellitus before study treatment; b)
poorly controlled hypertension; c) history of hypertensive crisis or hypertensive
encephalopathy;
12. Unstable thrombotic events requiring therapeutic intervention within 6 months before
screening;
13. Patients with active central nervous system metastasis;
14. Patients with pleural effusion, pericardial effusion or ascites with clinical
symptoms or requiring repeated drainage;
15. Had allergic history to recombinant humanized antibody or human-mouse chimeric
antibody or to any of BL-B01D1's excipients;
16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation
(Allo-HSCT);
17. Human immunodeficiency virus antibody positive, active tuberculosis, active
hepatitis B virus infection or active hepatitis C virus infection;
18. Active infection requiring systemic therapy;
19. Had participated in another clinical trial within 4 weeks before the first dose;
20. Who have a history of psychotropic drug abuse and cannot abstain from it or have
mental disorders;
21. Other circumstances that the investigator deemed inappropriate for participation in
the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chaosu Hu
Investigator:
Last name:
Chaosu Hu
Email:
Principal Investigator
Investigator:
Last name:
Dongmei Ji
Email:
Principal Investigator
Start date:
June 7, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06437522
