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
Overview
- Phase
- Phase 2
- Intervention
- BL-B01D1
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Recommended Phase II Dose (RP2D)
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Study treatment
Participants receive BL-B01D1 + PD-1 monoclonal antibody 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.
Intervention: BL-B01D1
Study treatment
Participants receive BL-B01D1 + PD-1 monoclonal antibody 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.
Intervention: PD-1 monoclonal antibody
Outcomes
Primary Outcomes
Recommended Phase II Dose (RP2D)
Time Frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
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).
Secondary Outcomes
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)