Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2026-03-03
254
Participants Needed
2
Research Sites
156 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 HLX37 in patients with advanced/metastatic solid tumors.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate by signing informed consent
- Age between 18 and 75 years with no gender restrictions
- Histologically or cytologically confirmed advanced or metastatic solid tumors or locally advanced/metastatic NSCLC not suitable for radical treatment
- Failed at least one standard systemic treatment for advanced/metastatic disease or have no effective standard treatment
- For NSCLC without driver gene alterations, confirmed negative results for EGFR and ALK (non-squamous); no alterations in ROS1, NTRK, BRAF, MET exon 14 skipping, or RET
- For NSCLC with driver gene alterations, prior failure of at least one standard treatment including targeted therapy
- At least one measurable lesion per RECIST 1.1 within 4 weeks before first administration (brain metastases not target lesions)
- ECOG performance status 0-1 within 7 days before first administration
- Expected survival longer than 3 months
- Adequate recovery and intervals from prior treatments before first study drug administration
- Agree to provide tumor tissue samples for PD-L1 testing
- Adequate organ function verified by labs within 7 days before first administration
- Child-Pugh score A for hepatocellular carcinoma patients
- Agree to use effective contraception during study and for 6 months after last dose; negative pregnancy test for females of childbearing potential
You will not qualify if you...
- History of other malignancies within 3 years except cured cervical carcinoma in situ or basal cell carcinoma
- Past severe immune-related adverse events or grade ≥2 immune-related pneumonia or myocarditis
- History or active non-infectious interstitial lung disease requiring steroids
- Known severe allergic reactions to monoclonal antibodies or test drug components
- Active systemic infections requiring IV antibiotics within 2 weeks prior to first dose
- Poorly controlled cardiovascular or cerebrovascular diseases including NYHA class II or above heart failure, recent myocardial infarction or stroke, unstable angina, or significant arrhythmias
- Recent serious gastrointestinal or thromboembolic events within 6-12 months prior to first dose
- Known active or symptomatic CNS metastases not meeting stability criteria
- Active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Use of systemic corticosteroids or immunosuppressants within 14 days prior to first dose except specified exceptions
- Active pulmonary tuberculosis
- History or current significant bleeding disorders or high bleeding risk tumors
- Recent use of high-dose aspirin, antiplatelets, or therapeutic anticoagulants within 7 days prior to first dose
- Chronic daily use of NSAIDs for long-term treatment
- Prior grade ≥3 toxicity from anti-angiogenic therapy
- Immune deficiency states including HIV or history of organ transplantation
- Active hepatitis B or C infection or co-infection not meeting viral load criteria
- Receipt of live vaccine within 28 days prior to first dose
- Pregnant or breastfeeding women
- Other clinical or laboratory abnormalities or diseases judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
2
The Second Affiliated Hospital of Air Force Medical University of the People's Liberation Army of China
Xi'an, China
Actively Recruiting
Research Team
L
Liya Wan
CONTACT
T
Tianqing Chu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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