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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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%;

⁃ No blood transfusion or colony-stimulating factor was allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;

⁃ Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;

⁃ Urinary protein ≤1+ or ≤1000mg/24h;

⁃ Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2026-11
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Experimental: 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.
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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