Actively Recruiting
A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors
Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2025-11-25
262
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
S
Sichuan Huiyu Pharmaceutical Co., Ltd
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years to 75 years at the time of signing informed consent
- Expected survival of at least 3 months as assessed by investigator
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Cytologically or pathologically confirmed advanced solid tumors with failed standard treatment
- Evaluable tumor lesions for dose escalation stage or at least one measurable tumor lesion for dose expansion stage based on RECIST 1.1
- Adequate main organ function
- Positive mesothelin (MSLN) expression confirmed by tissue testing
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first drug administration and agree to use effective contraception during the study and for 6 months after
- Male participants must agree to use effective contraception during the study and for 6 months after
- Postmenopausal women must have been amenorrheic for at least 12 months to be considered non-childbearing
You will not qualify if you...
- Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before first drug administration
- Participated in other investigational drug or interventional medical device studies within 4 weeks before first drug administration
- Received or planned to receive live/attenuated or mRNA vaccines within 4 weeks before screening
- Pregnant or breastfeeding women
- Ongoing adverse events from previous anti-tumor therapy greater than Grade 1 before first drug administration
- History of Grade 3 or higher immune-related adverse events or discontinued immunotherapy due to immune-related adverse events
- Primary central nervous system tumors, symptomatic CNS metastases, meningeal metastases, or history of epilepsy
- Major surgery on vital organs within 4 weeks before first drug administration or need for major elective surgery during trial
- History of tissue or organ transplantation
- Severe infections within 4 weeks before first drug administration
- Positive HIV test
- Active or uncontrolled hepatitis B or active hepatitis C infection
- Positive treponema pallidum antibody confirmed by diagnostic test
- Untreated or ongoing tuberculosis
- Severe allergic history or reactions to macromolecular protein preparations/antibodies or investigational drug components
- History of active autoimmune diseases or autoimmune diseases with risk of recurrence
- Systemic glucocorticoids or immunosuppressants within 14 days before first drug administration
- History of non-infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease
- History of severe cardiovascular or cerebrovascular diseases
- Thrombosis or bleeding risk
- Psychoactive substance abuse or drug use affecting study compliance
- Active malignant tumors other than study tumor within 1 year before first drug administration
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage
- Deemed unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chun Wan
CONTACT
L
Lin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here