About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HY05350 for injection
- HY05350 for injection
Treatment groups
Sponsors and collaborators
Sichuan Huiyu Pharmaceutical Co., Ltd
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator