A Study 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

NCT06668961 | Recruiting Phase 2

• 1 other identifier: SI-B001-SI-B003-203
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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.

  Up to approximately 24 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Cohort A

EXPERIMENTAL

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.

Drug: SI-B001; Drug: SI-B003

Cohort B

EXPERIMENTAL

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.

Drug: SI-B001

Interventions

SI-B001 DRUG

Administration by intravenous infusion

Cohort A; Cohort B

SI-B003 DRUG

Administration by intravenous infusion

Cohort A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Had received immunotherapy and had grade ≥3 irAE or grade ≥2 immune-related myocarditis;
• Received live attenuated vaccine within 4 weeks before the first dose of study drug;
• Had taken an immunomodulatory drug within 14 days before the first dose of study drug;
• Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• Other malignant tumors within 5 years before the first administration;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)