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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
TQB2102 Injection is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug.
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.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1
To evaluate the Progression-Free Survival (PFS) assessed by IRC of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: 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
Overall Survival (OS)
To evaluate the Overall Survival (OS) of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: 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
Objective Response Rate (ORR)
To evaluate the Objective Response Rate (ORR) of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: 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
Duration of Response (DOR)
To evaluate the Duration of Response (DOR) of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: 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
Disease Control Rate (DCR)
To evaluate the Disease Control Rate (DCR), of TQB2102 Injection compared to investigator-selected chemotherapy in subjects
Time frame: 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
Time to Response (TTR) (assessed by both IRC and investigators)
To evaluate the Time to Response (TTR) (assessed by both IRC and investigators), of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: 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
Investigator-assessed PFS
To evaluate the investigator-assessed PFS of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: 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
Survival rates at 3 months, 6 months, 9 months, and 12 months
To evaluate the Survival rates at 3 months, 6 months, 9 months, and 12 months of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Time frame: Baseline, 3, 6, 9, 12 months
Quality of life scores at 3 months, 6 months, 9 months, and 12 months
To evaluate the quality of life scores at 3 months, 6 months, 9 months, and 12 months of TQB2102 Injection compared to investigator-selected chemotherapy in subjects. Higher scores indicate more severe conditions.
Time frame: Baseline, 3, 6, 9, 12 months
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Pharmacokinetic (PK)-Ctrough
Exploration of the Pharmacokinetic Characteristics of TQB2102 Injection Using Trough Concentrations.
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 4, Cycle 7, and Cycle 12 (each cycle is 21 days)
Immunogenicity of TQB2102: ADA incidence
Exploration of Anti-Drug Antibody (ADA) Characteristics for TQB2102 Injection.
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, 4, 7, and 12, and 90 days after last infusion. (Each cycle is 21 days)
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
The first affiliated hostpital of guangzhou medical university (national center for respiratory medicine)
Guangzhou, Guangdong, China
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
Meizhou People's Hospital(Huangtang Hospital) Meizhou Academy of Medical Sciences
Meizhou, Guangdong, China
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