This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 for Injection (Subcutaneous) in participants with advanced solid tumors.
Written informed consent;
≥18 years old and ≤80 years old, gender: male or female;
Dose escalation part: cytologically or histopathologically confirmed locally advanced or advanced solid tumor that has failed standard therapy, or for which no standard therapy exists, or for which standard therapy is not tolerated or has been refused (for tumor types for which PD-1/PD-L1-related inhibitors are approved in China, failure of prior PD-1/PD-L1-related inhibitor therapy is required). Solid tumors in the dose expansion part include non-small cell lung cancer (driver gene-negative), gastric cancer, esophageal cancer, Microsatellite Instability-High / Mismatch Repair-Deficient Solid Tumors (MSI-H/dMMR) solid tumors, cervical cancer, non-muscle-invasive bladder cancer, head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma), renal cell carcinoma, and other tumor types;
Dose escalation part: at least one evaluable tumor lesion is required. Dose expansion part: at least one measurable tumor lesion is required (per RECIST v1.1);
Within the defined washout periods for prior anti-cancer treatments;
Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.
Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.
Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).
Sequential
Test Product HY07121 for Injection (Subcutaneous)
DrugDosage form: Powder for solution for infusion. Strength: 10 mg/vial. Method of administration: Subcutaneous administration. Dose escalation: "3+3" dose escalation rules are used to explore the safety and tolerability of the drug HY07121 for Injection (Subcutaneous).Based on emerging clinical data, dose escalation of an SUD-containing regimen may also follow a standard "3+3" design. Dose expansion: according to the preliminary safety and efficacy results of the dose escalation study, an appropriate dose and tumor species for the expansion study are conducted as discussed by the sponsor and investigators to further explore the safety and clinical effectiveness of the drug product HY07121 for Injection (Subcutaneous) and provide a basis for subsequent clinical studies.
Test Product HY07121 for Injection (Subcutaneous)
DrugDosage form: Powder for solution for infusion. Strength: 10 mg/vial. Method of administration: I Subcutaneous administration. Dose escalation: "3+3" dose escalation rules are used to explore the safety and tolerability of the drug HY07121 for Injection (Subcutaneous).Based on emerging clinical data, dose escalation of an SUD-containing regimen may also follow a standard "3+3" design. Dose expansion: according to the preliminary safety and efficacy results of the dose escalation study, an appropriate dose and tumor species for the expansion study are conducted as discussed by the sponsor and investigators to further explore the safety and clinical effectiveness of the drug product HY07121 for Injection (Subcutaneous) and provide a basis for subsequent clinical studies.
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)
Dose-Limiting Toxicity (DLT) will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Dose Escalation (Part One): Percentage of participants experiencing Adverse Event (AE) related dose interruptions, dose delays, and dose intensity
Occurrence of Adverse Event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure)
Dose Expansion (Part Two): Objective Response Rate (ORR)
Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)
Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Dose Expansion (Part Two): Percentage of participants experiencing adverse event (AE) related dose interruptions, dose delays, and dose intensity
Occurrence of adverse event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure).
Dose Escalation and Expansion: Assessment of HY07121 Cmax
Maximum concentration observed (Cmax) observed from the pharmacokinetic profile
Dose Escalation and Expansion: Assessment of HY07121 AUC
Area under the concentration versus time curve calculated using the trapezoidal method
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