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

NCT07083323 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

HY05350 for injection

HY05350 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.

DRUG

HY05350 for injection

HY05350 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.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Sichuan Huiyu Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Chun Wan · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083323 on ClinicalTrials.gov