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
1 other identifier
interventional
142
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2026
Typical duration for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 6, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 19, 2026
December 1, 2025
1.4 years
March 6, 2026
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Secondary Outcomes (11)
Overall Survival (OS)
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)
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)
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)
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)
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
- +6 more secondary outcomes
Study Arms (2)
TQB2102 Injection
EXPERIMENTALTQB2102 Injection, 21days as a treatment cycle, administered on Day 1 of each cycle
Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets
EXPERIMENTALTAS-102 tablets: Oral administration, 35 mg/m² (maximum single dose: 80 mg), twice daily on Days 1-5 and Days 8-12. Each treatment cycle is 4 weeks (Q4W). Fruquintinib: Oral administration, 5 mg once daily (QD), on Days 1-21 of each cycle. Each treatment cycle is 4 weeks (Q4W). Regorafenib tablets: Oral administration, 160 mg once daily (QD), on Days 1-21 of each cycle. Each treatment cycle is 4 weeks (Q4W).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A history of other malignant tumors within 3 years prior to the first dose, or concurrent malignant tumors at screening. Subjects are eligible for enrollment if they meet one of the following two conditions:
- Other malignant tumors treated with curative intent via a single surgical procedure, with disease-free survival (DFS) maintained for 5 consecutive years;
- A history of cured carcinoma in situ of the cervix, non-melanoma skin cancer, or superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\].
- Presence of diseases that affect intravenous injection or venous blood collection, or factors that impair oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.).
- Failure of adverse reactions from prior treatments to resolve to ≤ Grade 1 per CTCAE v5.0, with the following exceptions: Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, type 1 diabetes mellitus and hypothyroidism stabilized with hormone replacement therapy, and other toxicities judged by the investigator to pose no safety risks.
- Receipt of major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose; or planned major surgery during the study period (excluding surgeries specified in the protocol); or presence of unhealed wounds or fractures for a prolonged period.
- Clinically significant tumor bleeding or perforation within 1 month prior to the first dose; or any bleeding event ≥ Grade 3 per CTCAE v5.0; or subjects with bleeding or coagulation disorders receiving warfarin, aspirin, or other antiplatelet agents (excluding maintenance doses: aspirin ≤ 100 mg/day, clopidogrel ≤ 75 mg/day); or subjects with a history or signs of bleeding deemed ineligible by the investigator.
- A history of thrombotic or embolic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) \[excluding subjects with isolated calf vein thrombosis ≤ 7 mm in diameter, ≤ 5 cm in length, not involving ≥ 2 veins, and assessed by the investigator as having no risk of thrombus progression\], and pulmonary embolism, etc.
- Presence of major cardiovascular diseases.
- A history of decompensated liver cirrhosis or hepatic encephalopathy.
- Subjects with active chronic hepatitis B or active chronic hepatitis C. Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening must undergo additional testing for Hepatitis B Virus (HBV) DNA titer or HCV RNA quantification.
- Active syphilis infection requiring treatment.
- A history of (non-infectious) pneumonitis/interstitial lung disease requiring corticosteroid therapy; or current diagnosis of non-infectious pneumonitis/interstitial lung disease; or hospitalization for any active infection or receipt of therapeutic antibiotics within 4 weeks prior to the start of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Active or uncontrolled severe infection (≥ Grade 2 infection per CTCAE v5.0).
- A history of psychoactive substance abuse with inability to abstain, or presence of mental disorders.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
The first affiliated hostpital of guangzhou medical university (national center for respiratory medicine)
Guangzhou, Guangdong, 510000, China
Sun Yat-sen university cancer center
Guangzhou, Guangdong, 510050, China
Meizhou People's Hospital(Huangtang Hospital) Meizhou Academy of Medical Sciences
Meizhou, Guangdong, 514000, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530000, China
The People's Hospital of Guizhou Province
Guiyang, Guizhou, 550002, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311, China
Cancer Hospital Chinese Academy pf Medical Seciences
Langfang, Hebei, 650000, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, 150006, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110801, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000, China
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
Xi'an, Shaanxi, 710004, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029, China
Linyi people's Hospital
Linyi, Shandong, 276000, China
Linyi Cancer Hospital
Linyi, Shandong, 276034, China
ZhongShan Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Introduction Of Shanxi Cancer Hospital
Taiyuan, Shanxi, 300000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 300010, China
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital
Chengdu, Sichuan, 610000, China
Sichuan Provincial Cancer Hospital (Sichuan Provincial Cancer Prevention and Treatment Center of the Second People's Hospital of Sichuan Province)
Chengdu, Sichuan, 610041, China
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, 300121, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310017, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2026
First Posted
March 19, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
March 19, 2026
Record last verified: 2025-12