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RECRUITING
NCT07653685
PHASE1/PHASE2

A Clinical Trial Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Patients With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic 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 sparticipants with HER2-Abnormally Expressed 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 Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2026-09-03

Completion Date

2028-12

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride 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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks VEGF binding to receptors and inhibits tumor angiogenesis.

DRUG

TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)

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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.

Locations (31)

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Gansu Provincial Tumor Hospital

Lanzhou, Gansu, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 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

Qiqihar First Hospital

Qiqihar, 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

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Jiangxi Provincal People's Hospital

Nanchang, Jiangxi, 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