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ACTIVE NOT RECRUITING
NCT04603287
PHASE1

A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001. In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of SI-B001 in patients with locally advanced or metastatic epithelial tumors will be evaluated.

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2020-04-17

Completion Date

2025-12

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

DRUG

SI-B001

Administration by intravenous infusion.

Locations (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China