TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.
Study participants voluntarily enroll in this study, sign the informed consent form, and demonstrate good treatment compliance.
Age ranging from 18 to 75 years (calculated based on the date of informed consent signature).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Estimated survival time exceeding 12 weeks.
Exclusion Criteria Subjects satisfying any of the following criteria shall be excluded from this trial: Prior treatment with GPC3-targeted agents or other antibody-drug conjugates (ADCs) utilizing topoisomerase I inhibitors as cytotoxic payloads.
Diagnosis of another malignant tumor within 5 years prior to the first study dose, or concurrent secondary malignancy at screening. Eligible exceptions are as follows: other malignancies cured by single surgical resection with a continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, papillary thyroid carcinoma, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive carcinoma), Tis (carcinoma in situ), T1 (tumor invading lamina propria)].
Medical conditions interfering with intravenous injection or venous blood collection (including but not limited to active phlebitis, severe lymphedema, extensive cutaneous infection, etc.).
Unresolved adverse toxicities higher than NCI CTCAE Grade 1 stemming from prior therapies, excluding alopecia, skin pigmentation, and toxicities deemed by the Investigator to carry no safety risks.
Single group
TQB6426 for Injection
DrugTQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.
Dose-Limiting Toxicity (DLT)
Study participants experienced protocol-specified adverse events related to the investigational drug within one cycle (21 days) of receiving the investigational drug.
Maximum Tolerated Dose
The highest dose at which less than 33% of study participants experience dose-limiting toxicity (DLT)
Recommended Phase II Dose
The dose level of TQB6426 recommended for the further clinical trail studies based on assessment of the safety, efficacy and PK data from this study.
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs)
Maximum Concentration (Cmax)
Cmax refers to the maximum drug concentration in plasma after administration.
Area under the plasma drug concentration-time curve from time zero to the time of the last accurately quantifiable concentration (AUC0-t)
AUC0-t refers to the total systemic exposure to the drug from the time of administration until the last accurately quantifiable concentration is observed.
Area under the plasma concentration-time curve extrapolated from time zero to infinite time（AUC0-∞）
AUC0-∞ refers to the total systemic exposure to the drug from the time of administration to infinite time .
Time to peak concentration (Tmax)
The time from drug administration to the time point of the maximum observed plasma drug concentration.
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