A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- SI-B001
- Conditions
- Not specified
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This study is a open, multi-center phase II clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of SI-B001+SI-B003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •Gender is not limited;
- •Age ≥18 years old and ≤75 years old;
- •Expected survival time ≥3 months;
- •Patients with recurrent or metastatic head and neck squamous cell carcinoma;
- •Consent to provide tumor tissue samples or fresh tissue samples archived from the primary or metastatic lesions within 2 years;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •Physical status score: ECOG ≤1;
- •The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
Exclusion Criteria
- •Squamous cell carcinoma of the nasopharynx, salivary gland, paranasal sinus, skin or of unknown primary site;
- •Patients with any of the following conditions were not eligible for the study: a) suitable and willing for local treatment; b) received systemic therapy, excluding treatment for locally advanced disease as part of multimodal therapy;
- •Patients with active central nervous system metastasis;
- •Who had participated in any other clinical trial within 4 weeks before the study dose;
- •Received radiotherapy within 4 weeks before the first dose of study drug;
- •Use of traditional Chinese medicine with anti-tumor indications within 2 weeks;
- •Had undergone major surgery within 4 weeks before the first dose;
- •Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
- •Pulmonary disease was defined as ≥ grade 3 according to NCI-CTCAE v5.0; Patients with existing or a history of interstitial lung disease (ILD);
- •Have active infection requiring intravenous anti-infective therapy;
Arms & Interventions
Cohort A
Participants will receive treatment during the first cycle. 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: SI-B001
Cohort A
Participants will receive treatment during the first cycle. 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: SI-B003
Cohort B
Participants will receive treatment during the first cycle. 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: SI-B001
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Secondary Outcomes
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Duration of response (DOR)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)