Not Yet RecruitingPhase 3

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

China142 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The subject voluntarily participates in this study, signs the informed consent form, and has good compliance. * Aged 18 to 75 years old (calculated as of the date of signing the informed consent form). * Subjects with histologically or cytologically confirmed advanced colorectal cancer. * The subject has confirmed HER2 IHC3+ status in tumor tissue, as determined by the central laboratory designated by the sponsor. * The subject must provide a sufficient quantity of qualified tumor specimens (fresh or archived samples collected within the past 3 years from primary or metastatic lesions) for central laboratory testing of HER2 status. * Advanced colorectal cancer that has progressed on or been intolerant to at least 2 prior lines of standard therapy (defined as disease progression or intolerable toxicity during or within 3 months after the last standard therapy). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Expected survival of greater than 12 weeks. * Presence of at least one measurable lesion as confirmed by RECIST 1.1 criteria. * Laboratory tests must meet criteria * Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the study ends, and have a negative serum or urine pregnancy test within 7 days prior to study entry. Men must agree to use effective contraception during the study and for 6 months after the study ends. Exclusion Criteria: * A history of other m…

What they're measuring

Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months

Trial details

NCT IDNCT07483684

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Ruihua Xu, Doctor

020-87343468 xurh@syscc.org.cn