A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. Aged ≥18 years and ≤75 years at the time of signing the informed consent form, regardless of gender. 2. Investigator-assessed expected survival period ≥3 months. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 4. Patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment. 5. Subjects enrolled in the dose escalation stage must have evaluable tumor lesions, and subjects enrolled in the dose expansion stage must have at least one measurable tumor lesion (based on RECIST 1.1). 6. Participant must have adequate main organ function. 7. Agree to provide archived pathological tissues or fresh biopsy tumor tissues for detection of related markers such as MSLN and Programmed cell death ligand 1 (PD-L1) expression levels, and MSLN expression is positive. 8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first drug administratio