Actively Recruiting
A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours
Led by Ganzhou Hemay Pharmaceutical Co., Ltd · Updated on 2026-03-03
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary anti-tumor effects and safety of Hemay181 in adults with advanced solid tumors who have not responded to standard treatments or have no effective standard therapy available. This open-label Phase I clinical study focuses on patients with measurable lesions that can be assessed using CT or MRI scans. The study aims to measure how well Hemay181 works by monitoring the time until tumor progression or death. Participants receive Hemay181 as an intravenous infusion once every three weeks during each treatment cycle. The study does not include a placebo group and is designed to observe the effects and safety of this drug over time. The treatment period continues until the patient experiences disease progression or death, with assessments lasting up to 100 months. During the study, participants will have regular evaluations including imaging scans to track tumor size and laboratory tests to monitor safety. Researchers will follow patients closely from the start of treatment until progression or death, with a focus on both efficacy and safety indicators. The total duration of participation varies depending on individual response and disease progression.
CONDITIONS
Brief Title
A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form before starting the study
- Pathologically confirmed advanced solid tumors with no response to standard therapies or no effective standard treatment available
- At least one measurable tumor lesion evaluable by CT or MRI according to RECIST V1.1
- At least 4 weeks or 5 half-lives since last treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, or major surgery) with recovery from side effects to Grade 1 or less (except alopecia any grade, hyperpigmentation any grade, or peripheral sensory neuropathy Grade 2 or less)
- ECOG performance status score of 0 or 1
- Expected survival of more than 3 months
- Women of childbearing potential (including partners) must not plan pregnancy and agree to use effective contraception from consent until 6 months after last dose
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HIV, syphilis, hepatitis B with high HBV-DNA, or hepatitis C with high HCV-RNA
- Received drug treatment in another clinical trial within 4 weeks before enrollment
- Allergy to the study drug or its ingredients
- History of alcohol or drug abuse, dependence, or severe mental illness
- Considered unsuitable by the investigator due to any clinical or laboratory abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until disease progression or discontinuation, assessed up to 100 months
Participants receive Hemay181 through intravenous infusion once every 3 weeks.
Infusions once every 3 weeks with additional visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Xinxiang Medical University First Affiliated Hospital
Xinxiang, Henan, China, 45310
Actively Recruiting
Research Team
X
Xu, Doctor
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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