Advanced Solid Tumors
Conditions
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 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.
Interventions
DRUGQL1706H
QL1706H is the subcutaneousely administered formulation of QL1706, it contains two unique monoclonal antibodies.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Serum Drug Concentration ( Ctrough) | one cycle (3 weeks) | The minimum serum drug concentration and area under serum concentration-time curve after single administration of QL1706H. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | one cycle (3 weeks) | Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0. |
Contacts
Primary ContactPeizhen Wang, bachelor
Outcome results
None listed