Actively Recruiting
HWS116 Monotherapy in Patients With Advanced Solid Tumors
Led by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company · Updated on 2026-04-28
56
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 monotherapy in patients with advanced solid tumors.
CONDITIONS
Official Title
HWS116 Monotherapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of signing the informed consent form
- Have recurrent or metastatic solid tumors confirmed by histology or cytology
- Tumors have progressed or are intolerant to standard treatments or no standard treatments are available or suitable
- Have at least one evaluable or measurable lesion according to RECIST 1.1
- Life expectancy of 12 weeks or more
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate function of main organs
- Agree to use two medically approved effective contraceptive methods during the study and for 6 months after last dose if capable of having children
- Negative serum pregnancy test within 7 days before dosing for women of childbearing potential
- Understand the study, voluntarily sign informed consent, and can follow study procedures and follow-up requirements
You will not qualify if you...
- Known allergy to HWS116, drugs of the same class, or any excipients
- Previous treatment with any FGF-FGFR pathway inhibitor
- Received chemotherapy, targeted therapy, endocrine therapy, herbal or physiotherapy within 14 days or within 5 half-lives of the drug before first dose
- Received surgery (except diagnostic biopsy), radiotherapy (except palliative for non-target lesions within 14 days), biotherapy, immunotherapy, or other anti-tumor therapies within 28 days or within 5 half-lives of the drug before first dose
- Major surgery within 28 days before first dose
- Grade 2 or higher toxicity from previous anti-tumor treatment before first dose, except certain low-risk conditions
- Corneal defects, abnormalities increasing risk of corneal ulcer, or corneal surgery within 6 months before first dose
- Severe cardiovascular or cerebrovascular diseases
- History of significant QT interval prolongation or QTc >480 msec at screening
- Symptomatic or active progressing central nervous system metastases
- Positive for hepatitis B surface antigen with high viral load (except hepatocellular carcinoma), hepatitis C antibody with active infection, HIV, or active syphilis
- Autoimmune diseases, immunodeficiencies, history or planned organ transplantation
- Severe uncontrolled clinical conditions unsuitable for study
- Acute inflammation or active infections
- History of alcohol or drug abuse
- Pregnant or lactating women or women planning pregnancy or lactation during the study
- Any other condition judged by investigators as unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
Ruihua Xu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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