This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive advanced solid tumors.
Aged ≥18 years and ≤75 years at the time of signing the informed consent form, regardless of gender.
Investigator-assessed expected survival period ≥3 months.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.
Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy and other anti-tumor therapies within 4 weeks before the first drug administration.
Received other investigational drugs or participated in interventional medical device studies within 4 weeks before the first drug administration.
Had received or planned to receive live/attenuated vaccines or mRNA vaccines within 4 weeks before screening.
Pregnant or lactating women.
Sequential
HY05350 for injection
DrugHY05350 should be administered intravenously at planned dosage, once a week, once every two weeks, or once every three weeks, until disease progression or intolerable toxicity occurs.
HY05350 for injection
DrugHY05350 should be administered intravenously at recommended dose, once a week, once every two weeks, or once every three weeks, until disease progression or intolerable toxicity occurs.
Part 1, the occurrence of dose limiting toxicity (DLT)
Measure Description: DLT will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) criteria for Cytokine Release Syndrome (CRS).
Part 1, Incidence of Treatment-Emergent Adverse Events (TEAE)
Measure Description: Incidence and severity of TEAE according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Part 2, Objective Response Rate (ORR)
Measure Description: The proportion of participants who have a Complete Response (CR) or a Partial Response (PR) based on Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.
Part 1, Peak Plasma Concentration (Cmax)
Measure Description: Maximum concentration observed from the pharmacokinetic profile
Part 1, Area under the plasma concentration versus time curve (AUC)
Measure Description: Area under the concentration versus time curve calculated using the trapezoidal method.
Part 1, Assessment of Anti-drug Antibody (ADA)
Measure Description: Incidence, duration, titer of serum anti-HY05350 antibody (ADA)
Part 1, Objective Response Rate (ORR)
Measure Description: Proportion of participants who have a complete response (CR) or a partial response (PR) determined by Investigator per the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.
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Sichuan Huiyu Pharmaceutical Co., Ltd
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
