Status:
UNKNOWN
A Study of QL1706H in Patients With Advanced Solid Tumors
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, Phase Ⅰ study of QL1706H in patients with advanced solid tumors. The study will evaluate the pharmacokenetics, safety, tolerability and preliminary efficacy of QL1706H.
Detailed Description
The study is composed of 2 parts. Part 1 is a dose-escalation study to explore the pharmacokenetics (PK), safety, and tolerability of QL1706H. Part 2 of the study will explore the PK characteristics o...
Eligibility Criteria
Inclusion
- Subjects participate voluntarily and sign informed consent.
- Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery
- Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.
- Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.
- The extension of life is more than 3 months
- Vital organs' function is adequate for enrolling
- Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.
- Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.
Exclusion
- Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.
- There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.
- Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.
- Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study
- Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period
- Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.
- Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs
- Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) \>2000 IU/ mL or 10\^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06047431
Start Date
October 1 2023
End Date
December 1 2025
Last Update
September 21 2023
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