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A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX37 (Recombinant Human Bispecific Antibodies Against PD-L1 and VEGF) in Patients With Advanced/Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2026-03-03
254
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, first-in-human phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) characteristics of HLX37 in patients with advanced or metastatic solid tumors. The study focuses on patients who have not responded to standard treatments or have no effective standard options, including those with advanced non-small cell lung cancer (NSCLC). This trial aims to carefully evaluate HLX37 dosing and effects to understand its potential in this patient population. The study has multiple parts. In Phase Ia Part 1, patients receive escalating doses of HLX37 through intravenous infusion using a 3+3 dose escalation design, with a dose-limiting toxicity (DLT) observation period of 3 weeks after the first dose. In Phase Ia Part 2, patients with advanced NSCLC receive HLX37 combined with chemotherapy at increasing doses every 3 weeks, also with a 3-week DLT observation. Phase Ib will expand dose groups based on safety, efficacy, and PK data from earlier phases. Overall, seven dose levels are planned, with patients receiving the recommended Phase 2 dose identified during escalation. Participants will undergo regular monitoring including safety assessments, pharmacokinetic sampling, and tumor evaluations based on RECIST 1.1 criteria. The primary outcomes include DLTs within 21 days post first dose and maximum tolerated dose determination. Secondary outcomes track response rates, duration of response, progression-free survival, overall survival, and maximum drug concentration up to 24 months. Patients must meet specific health and organ function criteria, agree to tumor tissue sampling, and will be monitored closely throughout the study period, which may last up to two years for outcome assessments.
CONDITIONS
Brief 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...
- Age between 18 and 75 years at the time of informed consent
- Diagnosis of advanced or metastatic solid tumors confirmed by histology or cytology
- For Stage Ia Part 1: Failed at least one standard systemic treatment or no effective standard treatment available
- For Stage Ia Part 2: Locally advanced or metastatic NSCLC not suitable for radical treatment, meeting specific molecular testing criteria
- At least one measurable lesion per RECIST 1.1 within 4 weeks before first administration
- ECOG performance status of 0 or 1 within 7 days before first administration
- Expected survival period longer than 3 months
- Appropriate interval from prior major treatments before first study drug administration
- Agreement to provide archived tumor tissue or undergo biopsy for PD-L1 testing
- Adequate organ function confirmed by laboratory tests within 7 days before first administration
- Child-Pugh score A for hepatocellular carcinoma patients
- Use of effective contraception during the trial and for 6 months after last dose for fertile participants
- Negative pregnancy test within 7 days prior to enrollment for females of childbearing potential
You will not qualify if you...
- History of other malignant tumors within 3 years except certain cured skin or cervical cancers
- Past adverse events leading to permanent immunotherapy discontinuation or grade 2 or higher immune-related pneumonia or myocarditis
- History or active interstitial lung disease requiring steroid treatment or suspected risk of worsening ILD
- Severe allergic reaction to monoclonal antibodies or components of HLX37
- Active systemic infection requiring intravenous antibiotics within 2 weeks prior to first dose
- Poorly controlled cardiovascular or cerebrovascular diseases including heart failure, unstable angina, recent myocardial infarction or stroke, and arrhythmias
- Recent severe gastrointestinal or thromboembolic events within defined timeframes
- Known active or symptomatic central nervous system metastasis unless stable under specified conditions
- Active or suspected autoimmune diseases with exceptions for controlled hypothyroidism and type 1 diabetes
- Use of systemic corticosteroids or immunosuppressants within 14 days prior to first dose with specified exceptions
- Active pulmonary tuberculosis
- History of severe bleeding or coagulation disorders or high bleeding risk tumors
- Recent use of high-dose aspirin, anticoagulants, or thrombolytic drugs within 7 days before first dose
- Long-term daily use of non-steroidal anti-inflammatory drugs
- History of severe toxicity from prior anti-angiogenic therapy
- Immune deficiency including HIV, organ transplant history
- Active hepatitis B or C infection beyond specified viral load limits
- Receipt of live vaccine within 28 days prior to first administration
- Pregnant or breastfeeding women
- Any clinical or laboratory abnormalities or conditions deemed unsuitable by the investigator
- Local or systemic diseases unrelated to malignancy that increase medical risk or affect survival assessment
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 - 3 weeks after the first dose
Participants receive HLX37 at escalating doses via intravenous infusion with close safety monitoring to identify the maximum tolerated dose.
Multiple visits during the 3-week dose-limiting toxicity observation period
Duration - Up to 24 months
Participants receive HLX37 as an intravenous infusion every 3 weeks, either alone or in combination with chemotherapy depending on the study phase and cohort.
Infusions every 3 weeks with periodic safety and efficacy assessments
Duration - Approximately up to 24 months
Participants are monitored for safety, tolerability, and long-term outcomes including response duration and survival after treatment ends.
Periodic visits for assessments during follow-up period
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
T
Tianqing Chu
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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