RecruitingPhase 1Phase 2NCT07044908

TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS/BRAF Wild-type Advanced Colorectal Cancer

A Phase Ib/II Clinical Study Evaluating TQB2922 for Injection and Chemotherapy in Combination With or Without Bevacizumab in Subjects With RAS/BRAF Wild-Type Advanced Colorectal Cancer Who Have Failed Chemotherapy

Sponsor

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

Enrollment

72 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

RAS/BRAF Wild Type Colorectal Cancer

Summary

This is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — TQB2922 and TAS-102 tablets, with or without bevacizumab — for people with advanced colorectal (colon or rectal) cancer that has stopped responding to prior chemotherapy. The cancer must have a specific genetic profile (RAS/BRAF wild-type), meaning it lacks certain mutations that affect treatment response. **You may be eligible if...** - You are 18 or older with advanced colorectal cancer - Your tumor testing shows RAS and BRAF wild-type (no mutations in these genes) - Your cancer progressed after standard chemotherapy treatments - You have measurable disease on scans - Your overall health and organ function are adequate **You may NOT be eligible if...** - Your tumor has RAS or BRAF mutations - You have uncontrolled brain metastases - You have significant heart, bleeding, or clotting problems - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2922 injection ± TAS-102 tablets

TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype Immunoglobulin G1 (IgG1). TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.

DRUGTQB2922 injection+TAS-102 tablets ± Bevacizumab

TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype IgG1. TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.

Locations(27)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

National Cancer Center/Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Shantou University Medical College Affiliated Cancer Hospital

Shantou, Guangdong, China

Guangxi Zhuang Autonomous Region Cancer Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Xinyang Central Hospital

Xinyang, Henan, China

Zhoukou Central Hospital

Zhoukou, Henan, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Yibin First People's Hospital

Yibin, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT07044908