A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors

QL1706H-101

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.

2023-10-01

2024-12-01

2025-12-01

Not yet recruiting

Early phase I

150

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2023-09-21