a study of ql1706h in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

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.

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 of differente intervals and sites of administration. all the pk parameters will determine the recommended phase 2 dose (rp2d). the study was divided into screening/baseline, treatment and follow-up periods. safety monitoring will be conducted throughout the study period.

Eligibility criteria:
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