RecruitingPhase 2NCT06437522

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

A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

46 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

Subject volunteered to participate in the study and signed an informed consent;
Male or female aged ≥18 years and ≤75 years;
Expected survival time ≥3 months;
ECOG score 0-1;
Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and/or cytology;
Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
At least one measurable lesion meeting the RECIST v1.1 definition was required;
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;
The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
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 Criteria21

Prior treatment with an ADC drug with TOP I inhibitors as a toxin;
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;
Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma;
Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
Use of an immunomodulatory drug within 14 days before the first dose of study drug;
Systemic corticosteroids were required within 2 weeks before the first dose of the study;
Has a history of severe disease of heart head blood-vessel;
Active autoimmune and inflammatory diseases;
Other malignant tumors that progressed or required treatment within 3 years before the first dose;
With ILD requiring steroid treatment, current ILD, or suspected ILD at screening;
Presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy;
Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
Patients with active central nervous system metastasis;
Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage;
Had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;
Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
Active infection requiring systemic therapy;
Had participated in another clinical trial within 4 weeks before the first dose;
Who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders;
Other circumstances that the investigator deemed inappropriate for participation in the trial.