Actively Recruiting
A Study of HLX42 in Advanced/Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2025-09-22
102
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
CONDITIONS
Official Title
A Study of HLX42 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of signing the informed consent form, male or female
- Histologically or cytologically confirmed advanced/metastatic malignant solid tumors refractory or intolerable to standard treatment, or no standard treatment available (stage 1)
- Histologically or cytologically confirmed advanced/metastatic malignant NSCLC refractory or intolerable to standard treatment, or no standard treatment available (stage 2)
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status score of 0 or 1
- Life expectancy greater than 3 months
- Adequate organ function confirmed by laboratory tests within 7 days prior to first administration
- For hepatocellular carcinoma patients, Child-Pugh score must be A
You will not qualify if you...
- History of other malignant tumors within 2 years prior to first administration, except cured cervical carcinoma in situ or basal cell carcinoma of the skin
- Histopathological types of large cell carcinoma, adenosquamous carcinoma, or other specified types with neuroendocrine components (stage 2)
- History of or current interstitial lung disease requiring steroids, or suspected ILD not ruled out by imaging
- Allergy to protein preparations, monoclonal antibodies, or any component of the investigational product
- History of serious eye disorders
- Active systemic infections needing intravenous antibiotics within 2 weeks prior to first administration
- Poorly controlled cardiovascular or cerebrovascular symptoms or diseases
- Unsuitable for inclusion due to brain or spinal cord metastases or cancerous meningitis with clinical symptoms
- Use of long-term systemic steroids (>10 mg/day prednisone equivalent) or immunosuppressants within 2 weeks prior to first infusion
- Use of potent CYP2D6/CYP3A inhibitors or inducers within 2 weeks prior to first administration
- History of immunodeficiency including HIV or organ transplantation
- Active hepatitis B or C infection or co-infection
- Pregnant or breastfeeding women
- Any clinical or laboratory abnormalities or other reasons determined unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangdong, Guangzhou, China
Actively Recruiting
Research Team
Y
Yilong Wu, Dr.
CONTACT
H
Huajun Chen, Dr.
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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