Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
1. Fully understand this trial and voluntarily sign the informed consent form.
2. For locally recurrent or metastatic non-resectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions, while the dose-expansion stage is limited to NSCLC without standard of care, NSCLC with EGFR-sensitive mutations and progressing after adequate EGFR-TKI therapy. First-line population with driver gene negative non-small cell lung cancer and first-line population with extensive small cell lung cancer.
3. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).
4. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.
1. Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.
2. Combination of brain metastasis, meningeal metastasis and spinal cord compression.
3. Prior concurrent anti-programmed death receptor 1 (PD-1)/programmed death ligand (PD-L1), anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) target drugs.
4. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.
Sequential
HC010
DrugHC010 once every 3 weeks (Q3W) by intravenous drip
Paclitaxel (Chemotherapy)
Drugthe combination chemotherapy regimens are all commonly used in clinical practice
Pemetrexed
Drugthe combination chemotherapy regimens are all commonly used in clinical practice
Etoposide
Drugthe combination chemotherapy regimens are all commonly used in clinical practice
Carboplatin/Cisplatin
Drugthe combination chemotherapy regimens are all commonly used in clinical practice
Docetaxel
Drugthe combination chemotherapy regimens are all commonly used in clinical practice
Incidence of dose-limiting toxicities (DLTs)
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria;
Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria
Maximum concentration (Cmax) of HC010
Number of positive cases of HC010 anti-drug antibody (ADA)
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