Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2025-12-05
340
Participants Needed
2
Research Sites
209 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, tolerability, and pharmacokinetic characteristics of HLX43 in patients with advanced/metastatic solid tumors.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and agree to participate by signing informed consent
- Aged 18 to 75 years, male or female
- Have confirmed advanced or metastatic malignant solid tumors refractory to standard treatment or lacking standard treatment
- For phase Ib cohorts: Patients with specific NSCLC or thymic carcinoma conditions as defined by prior treatments and tumor characteristics
- Have at least one measurable tumor lesion within 4 weeks before treatment
- ECOG performance status of 0 or 1 within 7 days before treatment
- Life expectancy greater than 3 months
- Meet specific timing requirements from prior treatments before starting study drug
- Agree to provide tumor tissue samples for PD-L1 testing
- Adequate organ function confirmed by lab tests within 7 days before treatment
- Child-Pugh score A for hepatocellular carcinoma patients
- Agree to use effective contraception during and after the study; females must have a negative pregnancy test within 7 days before enrollment
You will not qualify if you...
- History of other cancers within 2 years except certain cured cancers
- Previous severe immune-related adverse events from immunotherapy
- History or presence of interstitial lung disease requiring steroids or suspected ILD
- Known allergy or anaphylaxis to protein drugs or study drug components
- Active systemic infections needing intravenous antibiotics within 2 weeks before treatment
- Poorly controlled cardiovascular or cerebrovascular conditions as specified
- Uncontrolled brain or spinal cord metastases causing symptoms
- Active or suspected autoimmune diseases, except some controlled cases
- Recent use of systemic corticosteroids or immunosuppressants within 14 days prior to treatment
- Use of CYP2D6 or CYP3A enzyme modulators within 2 weeks before treatment
- Active tuberculosis
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C infection or co-infection
- Receipt of live vaccines within 28 days before treatment
- Pregnant or lactating women
- Any other clinical or lab abnormalities making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
2
Xiangya Hospital Central South University
Changsha, Hu'Nan, China, 410008
Actively Recruiting
Research Team
J
Jie Wang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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