NCT07483684

A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs

A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Clinical Study to Evaluate Injection TQB2102 Versus Investigator's Choice of Treatment Regimens in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal cancer who have failed prior treatment with oxaliplatin, irinotecan, and fluoropyrimidine-based regimens. The primary endpoint of this study is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). Other secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), safety, and quality of life scores. Approximately 142 subjects are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the experimental group or the control group.

Conditions

• HER2 IHC3+ Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TQB2102 Injection	TQB2102 Injection is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug.
DRUG	Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets	TAS-102 Tablets: Antimetabolite antitumor drug; trifluridine inhibits DNA synthesis by incorporating into tumor cell DNA, while tipiracil increases trifluridine bioavailability by inhibiting its degradation. Fruquintinib Tablets: Oral small-molecule VEGFR inhibitor; blocks VEGFR 1/2/3 signaling to inhibit tumor angiogenesis, cutting off tumor nutrient and oxygen supply. Regorafenib Tablets: Multikinase inhibitor; targets VEGFR, PDGFR, Fibroblast Growth Factor Receptor (FGFR), and Raf kinases to inhibit tumor angiogenesis, cell proliferation, and metastasis.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-08-01
• Completion: 2028-12-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

48 sites across 1 country: China