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OncoMatch/Clinical Trials/NCT06668961

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

Is NCT06668961 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SI-B001 and SI-B003 for head and neck squamous cell carcinoma.

Phase 2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06668961Data as of May 2026

Treatment: SI-B001 · SI-B003This 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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: systemic therapy

Exception: excluding treatment for locally advanced disease as part of multimodal therapy

received systemic therapy, excluding treatment for locally advanced disease as part of multimodal therapy

Cannot have received: immunotherapy

Exception: unless grade <3 irAE and grade <2 immune-related myocarditis

Had received immunotherapy and had grade ≥3 irAE or grade ≥2 immune-related myocarditis

Cannot have received: radiotherapy

Received radiotherapy within 4 weeks before the first dose of study drug

Cannot have received: traditional Chinese medicine with anti-tumor indications

Use of traditional Chinese medicine with anti-tumor indications within 2 weeks

Cannot have received: major surgery

Had undergone major surgery within 4 weeks before the first dose

Cannot have received: autologous or allogeneic stem cell transplantation

Had autologous or allogeneic stem cell transplantation

Lab requirements

Blood counts

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

Cardiac function

No severe cardiac dysfunction, left ventricular ejection fraction ≥50%

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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