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First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm, ZL-1201 | Experimental | Single arm, ZL-1201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-1201 | Drug | Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0 | From the time of informed consent to 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics:AUC | The area under the curve (AUC) of serum concentration of the drug after the administration | Up to 30 days after last dose |
| Pharmacokinetics: Cmax | Maximum serum concentration(Cmax) of the drug after the administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Physician | Zai Laboratory | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US2004 | Phoenix | Arizona | 85259 | United States | ||
| US2005 |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Up to 30 days after last dose |
| Pharmacokinetics: t1/2 | Half-life(t1/2) of the drug | Up to 30 days after last dose |
| Pharmacokinetics: CL | Total body clearance of the drug | Up to 30 days after last dose |
| Pharmacokinetics: Vss | Volume of the distrubution at steady-state | Up to 30 days after last dose |
| Immunogenicity | Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity | Up to 30 days after last dose |
| Overall Response Rate (ORR) | ORR includes CR and PR | Up to 2 years after enrollment |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| US2001 | Rochester | Minnesota | 55905 | United States |
| US2003 | St Louis | Missouri | 63110 | United States |
| US2002 | New York | New York | 11776 | United States |
| CN1003 | Chongqing | Chongqing Municipality | China |
| CN1002 | Hangzhou | Zhejiang | China |