TQB2101 for Injection is an Antibody-Drug Conjugate (ADC) targeting Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1).It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.
Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.
Age between 18 and 75 years (calculated based on the date of signing the informed consent form).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Expected survival >12 weeks.
Patients with other malignant tumors that occurred within 3 years before the first administration or currently coexisting with other malignant tumors are excluded, except for those who have undergone a single surgical treatment for other malignant tumors and have achieved a disease-free survival (DFS) of 5 consecutive years; patients with cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)] are eligible for inclusion.
Lymphoma involving or suspected to involve the central nervous system, or primary central nervous system lymphoma;
Patients who have received chemotherapy, immunotherapy within 4 weeks before the first administration, radiotherapy or small molecule targeted drugs within 2 weeks, or are still within 5 half-lives of the drug (whichever occurs earlier), with a washout period calculated from the end of the last treatment;
Patients who have received treatment with traditional Chinese medicine with clear anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions (including Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea javanica Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.) within 2 weeks before the first administration;
Single group
TQB2101 for Injection
DrugTQB2101 for Injection is an ROR1 ADC, an antibody-drug conjugate. It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.
Dose-limiting toxicity
Dose-limiting toxicity (DLT) refers to any Grade 3-5 adverse event (as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0) considered related to the investigational drug and occurring from the first dose administration through the end of the first treatment cycle.
Maximum Tolerated Dose
Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT).
Phase II recommended dose
The recommended dose for subsequent phase II studies will be determined based on Maximum Tolerated Dose, Pharmacokinetics, preliminary efficacy and safety.
Overall Response Rate (ORR)
Proportion of subjects achieving best overall response of PR or CR.
Disease Control Rate (DCR)
Proportion of subjects achieving best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Progression-Free Survival (PFS)
The time from the first dose of the investigational drug to the first documented disease progression or death (from any cause), whichever occurs earlier.
Overall Survival (OS)
The time from the first dose of the investigational drug to the date of death due to any cause.
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