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| Name | Class |
|---|---|
| Zai Lab (US) LLC | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.
An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZL-6201 | Experimental | ZL-6201 as a single agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-6201 | Drug | ZL-6201 as a single-agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities | Number of subjects with dose limiting toxicities (DLTs) through dose escalation only. | 1 cycle of study treatment (each cycle is 21 days) |
| Incidence of Treatment Emergent Adverse Events | Number of subjects with treatment-emergent adverse effects through dose escalation and expansion. | 36 months |
| Incidence of Serious adverse events | Number of subjects with Serious Adverse Events through dose escalation and expansion. | 36 months |
| Number of participants with clinical laboratory abnormalities | 36 months | |
| Number of participants with vital sign abnormalities | Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute | 36 months |
| Number of participants with electrocardiogram (ECG) abnormalities | ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR per RECIST 1.1 | Objective Response Rate (ORR) is defined as the proportion of participants who have a best response of confirmed partial response (PR) or confirmed complete response (CR) to study treatment per RECIST v1.1 by investigator assessment through dose escalation and expansion. | 36 months |
| Duration of Response per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZL-6201-001 Study Team | Contact | (510)-316-3502 | ZL-6201-001@zailaboratory.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zai Lab Site 02003 | Recruiting | Los Angeles | California | 90007 | United States | |
| Zai Lab Site 02030 |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Duration of Response is defined as the time from the first assessment of CR or PR to the first assessment of progression disease (PD) by investigator per RECIST 1.1 or death due to any cause (whichever occurs first) through dose escalation and expansion. |
| 36 months |
| PFS per RECIST 1.1 | Progression-Free Survival (PFS) is defined as the time from first dosing date to the first documented PD by investigator per RECIST 1.1 or death for any reasons (whichever occurs first) through dose escalation and expansion. | 36 months |
| DCR per RECIST 1.1 | Disease Control Rate (DCR) is defined as the proportion of participants who have a best response of confirmed CR, confirmed PR, or SD per RECIST 1.1 by investigator assessment through dose escalation and expansion. | 36 months |
| PK characteristics of ZL-6201 (ADC conjugate), total antibody | Pharmacokinetics: Total Antibody of ZL-6201 | 36 months |
| PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads | Pharmacokinetics: Unconjugated payloads of ZL-6201 | 36 month |
| Recruiting |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Zai Lab Site 02026 | Recruiting | Sarasota | Florida | 34232 | United States |
|
| Zai Lab Site 02005 | Recruiting | St Louis | Missouri | 63160 | United States |
| Zai Lab Site 02002 | Recruiting | New York | New York | 10065 | United States |
| Zai Lab Site 02006 | Recruiting | Fairfax | Virginia | 22031 | United States |
|