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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

ConditionHER2 IHC3+ Advanced Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TQB2102 Injection

    Drug

    TQB2102 Injection is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug.

  • Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets

    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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: TQB2102 InjectionExperimental treatment 1 intervention
Group B: Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tabletsExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: