A Study of QL1706H in Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QL1706H Part 1 (Dose escalation): QL1706H will be administered in sequential cohorts each receiving 1 dose of QL1706H by subcutaneous injection on day 1 and QL1706 by IV infusion on day 22, from then on will recieve QL1706 on day 1 of every 21-day cycle (3 weeks). Dose escalation will continue until the projected cohorts has been finished. Part 2 (Dose Exploration): The PK parameters of QL1706H will be tested at different administration intervals. |
Drug: QL1706H
QL1706H is the subcutaneousely administered formulation of QL1706, it contains two unique monoclonal antibodies.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects participate voluntarily and sign informed consent.
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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
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Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.
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Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.
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The extension of life is more than 3 months
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Vital organs' function is adequate for enrolling
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Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.
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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:
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Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.
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There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.
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Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.
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Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study
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Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period
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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.
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Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Wei Lu, Doctor, Tianjin Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL1706H-101