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This is an open-label, Phase â… 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706H | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706H | Drug | QL1706H is the subcutaneousely administered formulation of QL1706, it contains two unique monoclonal antibodies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Serum Drug Concentration ( Ctrough) | The minimum serum drug concentration and area under serum concentration-time curve after single administration of QL1706H. | one cycle (3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0. | one cycle (3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peizhen Wang, bachelor | Contact | 18001246877 | peizhen.wang@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Lu, Doctor | Tianjin Cancer Hospital | Principal Investigator |
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