A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors (NCT07083323) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors
China262 participantsStarted 2025-07-22
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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).
✓. Participant must have adequate main organ function.
✓. 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.
✓. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first drug administration, and be willing to use effective contraceptive methods to prevent pregnancy and have no plans to donate eggs during the study period and for 6 months after the last drug administration. Male subjects must agree to have no plans to donate sperm and use effective contraceptive methods during the study period and for 6 months after the last drug administration. Postmenopausal women must have been amenorrheic for at least 12 months to be considered non-childbearing.
Exclusion criteria
✕. Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy and other anti-tumor therapies within 4 weeks before the first drug administration.
What they're measuring
1
Part 1, the occurrence of dose limiting toxicity (DLT)
Timeframe: At the end of Cycle 1 (each cycle is 28 days).
2
Part 1, Incidence of Treatment-Emergent Adverse Events (TEAE)
✕. 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.
✕. Subjects with adverse events caused by previous anti-tumor therapy that remained \> Grade 1 (based on CTCAE 5.0) before the first drug administration.
✕. Subjects with a history of ≥ Grade 3 immune-related adverse events or who discontinued immunotherapy due to irAE of any grade.
✕. Subjects with primary central nervous system (CNS) tumors, symptomatic CNS metastases, meningeal metastases, or a history of epilepsy are excluded.
✕. Subjects who underwent major surgery on vital organs (excluding biopsy) within 4 weeks before the first drug administration, experienced significant trauma, or require major elective surgery during the trial.