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NOT YET RECRUITING
NCT07653685
PHASE1/PHASE2

A Clinical Study of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in the Treatment of Advanced Colorectal Cancer

Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in subjects with HER2-positive unresectable locally advanced or metastatic colorectal cancer (CRC).

Official title: A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2026-07

Completion Date

2028-12

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection

TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks Vascular Endothelial Growth Factor (VEGF) binding to receptors and inhibits tumor angiogenesis.

DRUG

TQB2930 injection + Oxaliplatin injection + Capecitabine tablets

TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting Extracellular Domain 2 (ECD2) and Extracellular Domain 4 (ECD4), two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.

Locations (24)

Peking University First Hospital

Beijing, Beijing Municipality, China

Gansu Provincial Tumor Hospital

Lanzhou, Gansu, China

Guangxi Zhuang Autonomous Region Cancer Hospital

Nanning, Guangxi, China

The Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, China

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Jingzhou First People's Hospital

Jingzhou, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Provincial Cancer Hospital

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The first hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University Medical College

Xi'an, Shaanxi, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

The Second Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

Tianjin Union Medical Center

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Affiliated Tumor Hospital

Ürümqi, Xinjiang, China

Lishui Municipal Central Hospital

Lishui, Zhejiang, China