Actively Recruiting
A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors
Led by Ganzhou Hemay Pharmaceutical Co., Ltd · Updated on 2025-04-18
51
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will be conducted in about 51 participants in total. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor efficacy of Hemay181 in patients with advanced solid tumors.
CONDITIONS
Official Title
A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Signed informed consent before study entry
- Confirmed advanced solid tumors by pathology with standard therapy failure or no effective treatment
- At least one measurable lesion evaluable by CT or MRI per RECIST V1.1
- At least 4 weeks since last chemotherapy, targeted therapy, immunotherapy, radiotherapy, or major surgery; at least 2 weeks since endocrine therapy; recovered from prior treatment side effects to less than grade 1 except specified exceptions
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and kidney function within specified laboratory limits
- Commitment to use reliable contraception during the study and for at least 12 weeks after last dose
You will not qualify if you...
- Pregnant or breastfeeding women
- Known central nervous system metastatic disease
- Positive for HIV, active hepatitis B or C infection beyond normal limits
- Active infection requiring intravenous antibiotics
- History of severe irinotecan allergic reactions or gastrointestinal toxicity grade 3 or higher
- Participation in another clinical trial with drug therapy within 4 weeks prior to enrollment
- Known allergy to Hemay181 or its components
- Any clinical or laboratory abnormalities deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
Huiping Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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