Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Adults With HER2-Abnormal Locally Advanced or Metastatic Colorectal Cancer

What This Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of TQB2930 combined with chemotherapy, with or without bevacizumab, in people who have HER2-abnormally expressed, locally advanced or metastatic colorectal cancer that cannot be removed by surgery. This phase IbII clinical trial aims to better understand how these treatments work together to target cancer cells expressing the HER2 protein. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. and includes adult participants from 18 to 75 years old. Participants are randomly assigned to receive either TQB2930 injection plus chemotherapy and bevacizumab injection or TQB2930 injection plus chemotherapy alone. Chemotherapy drugs include oxaliplatin and capecitabine tablets or irinotecan hydrochloride injection with capecitabine tablets. TQB2930 targets HER2 proteins on tumor cells to reduce their growth, while bevacizumab works by blocking blood vessel formation that feeds tumors. Treatment continues until disease progression or other criteria are met. Throughout the study, participants undergo assessments such as measuring tumor response, monitoring adverse events, and collecting blood samples to analyze drug levels and immune responses. The main outcomes include determining the recommended dose for phase 2, safety monitoring from consent until 28 days after the last dose, and tracking objective response rates for up to 24 months. Secondary outcomes include survival rates, duration of response, and drug behavior in the body. Participants are monitored regularly during treatment and follow-up periods lasting up to two years.

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.