Status:
ACTIVE_NOT_RECRUITING
A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This phase I, first-in-human, open-label clinical study will evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX53 (an anti-TIGIT Fc fusion protein) in p...
Detailed Description
This study is an open-label phase I clinical study to evaluate the safety, tolerability , PK/PD and preliminary efficacy of HLX53 in patients with advanced/metastatic solid tumor. 11-30 subjects with ...
Eligibility Criteria
Inclusion
- Voluntary participation in clinical studies, full understanding of the trial, and signing of informed consent, willingness to follow and ability to complete the study in accordance with the requirements of the trial protocol.
- histologically or cytologically confirmed advanced/metastatic solid tumors or lymphoma, failure of standard therapy, or no standard therapy.
- Age ≥ 18 years and ≤ 75 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
- At least one measurable lesion according to RECISTv1.1 or 2014 Lugano (lymphoma) response evaluation criteria.
- Life expectancy of more than three months.
- Adequate hematological function.
- Adequate liver function.
- Adequate renal function
- Adequate cardiac function.
- Male and female subjects of childbearing potential must agree to use at least 1 highly effective method of contraception during the trial and for at least 6 months after the last dose of study drug.
Exclusion
- Known history of serious allergy to the components of HLX53 or to any monoclonal antibody.
- Prior treatment with anti-TIGIT or antibody to the relevant target CD155, CD112, or CD113.
- Unresolved toxicity after prior antineoplastic therapy, i.e., not resolved to baseline, Grade 0-1 per NCI-CTCAE 5.0 (except alopecia).
- Coexisting unstable or controlled medical conditions.
- Spinal cord compression with clinical symptoms.
- Prior allogeneic bone marrow transplant or solid organ transplant.
- History of primary immunodeficiency.
- History of eczema or asthma that cannot be controlled by topical corticosteroids.
- History of any second malignancy within 2 years, except for curatively treated early malignancies (carcinoma in situ or stage I tumors) such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, papillary thyroid cancer.
- Vaccination with a live attenuated vaccine within 4 weeks prior to the first dos.e
- Use of immunosuppressive drugs within 2 weeks prior to initial administration.
- Received major surgery, anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy or biological therapy) within 4 weeks prior to the first dose.
- Known to have active infectious disease such as active HBV, HCV infection.
- History of human immunodeficiency virus (HIV) infection.
- Pregnancy or lactation.
Key Trial Info
Start Date :
December 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05394168
Start Date
December 9 2022
End Date
March 4 2025
Last Update
April 1 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China