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This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Participants will be administered escalating doses of CS5007. |
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| Dose Expansion | Experimental | Participants will be administered the recommended dose(s) of CS5007 according to dose-escalation data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS5007 | Drug | CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). |
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| Measure | Description | Time Frame |
|---|---|---|
| [Dose Escalation] Maximum tolerated dose (MTD) of CS5007 | Participants will receive CS5007 via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). The MTD will be determined, if any, by the number of participants who experience a dose limiting toxicity (DLT). | Cycle 1 (Up to 21 Days) |
| [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS5007 | The selection of tentative RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The tentative RP2D may be the MTD or a lower dose within the tolerable dose range. | Up to approximately 2 years |
| [Dose Escalation] The incidence and severity of adverse events (AEs) | Up to approximately 2 years | |
| [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| [Dose Escalation & Expansion] Area under the curve (AUC) of CS5007 | Up to approximately 2 years | |
| [Dose Escalation & Expansion] Maximum concentration (Cmax) of CS5007 | Up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Yao | Contact | +86 18616365940 | yaosheng@cstonepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
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| [Dose Escalation & Expansion] Time to maximum concentration (Tmax) of CS5007 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Elimination half-life (t1/2) of CS5007 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Clearance (CL) of CS5007 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Volume of distribution (Vz) of CS5007 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Trough concentration (Ctrough) of CS5007 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Accumulation ratio (R) of CS5007 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Number of participants with anti-CS5007 antibodies | Up to approximately 2 years |
| [Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Duration of response (DOR) evaluated by investigators per RECIST v1.1 | Up to approximately 2 years |
| [Dose Escalation & Expansion] Disease control rate (DCR) evaluated by investigators per RECIST v1.1 | Up to approximately 2 years |
| [Dose Expansion] The incidence and severity of adverse events (AEs) | Up to approximately 2 years |
| Macquarie University | North Ryde | New South Wales | 2109 | Australia |
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| Calvary Mater Newcastle Hospital | Waratah | New South Wales | 2298 | Australia |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | 4101 | Australia |
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| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Linear Clinical Research Ltd | Nedlands | Western Australia | 6009 | Australia |
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| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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