drugset / Trial / NCT05668858

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

NCT05668858

Phase 1/2 Recruiting 130 enrolled Sichuan Baili Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 in combination and to identify RP2D in locally advanced or metastatic head and neck squamous cell carcinoma indications. Initial efficacy, pharmacokinetic characteristics and immunogenicity were evaluated. Phase II: To evaluate the efficacy of SI-B001+SI-B003 two-drug combination chemotherapy. Safety and tolerance, PK/PD, immunogenicity were evaluated.

Timeline

Start
2023-02-10
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject IZALONTAMAB Monoclonal antibody Intravenous
Subject SI-B003 Monoclonal antibody Intravenous