A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Huiyu Pharmaceutical Co., Ltd

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

262 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sichuan Huiyu Pharmaceutical Co., Ltd

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator