Description:
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
Title
- Brief Title: A Trial of ZL-1201 in Subjects With Advanced Cancer
- Official Title: First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
Clinical Trial IDs
- ORG STUDY ID:
ZL-1201-001
- NCT ID:
NCT04257617
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| ZL-1201 | Monotherapy | Single arm, ZL-1201 |
Purpose
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
Detailed Description
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Single arm, ZL-1201 | Experimental | Single arm, ZL-1201 | |
Eligibility Criteria
Inclusion Criteria:
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic
solid tumors and lymphomas that are refractory or intolerant to standard of care
therapy, or for which no standard therapy exists.
- Adequate hematologic status
- Adequate coagulation function
- Adequate hepatic function
- Adequate renal function
Exclusion Criteria:
- Known active brain metastases
- Red blood cells transfusion dependence
- Known cardiopulmonary disease
- Pregnant or breast-feeding females
- Any other serious underlying medical
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events |
| Time Frame: | From the time of informed consent to 30 days after last dose |
| Safety Issue: | |
| Description: | Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0 |
Secondary Outcome Measures
| Measure: | Pharmacokinetics：AUC |
| Time Frame: | Up to 30 days after last dose |
| Safety Issue: | |
| Description: | The area under the curve (AUC) of serum concentration of the drug after the administration |
| Measure: | Pharmacokinetics: Cmax |
| Time Frame: | Up to 30 days after last dose |
| Safety Issue: | |
| Description: | Maximum serum concentration(Cmax) of the drug after the administration |
| Measure: | Pharmacokinetics: t1/2 |
| Time Frame: | Up to 30 days after last dose |
| Safety Issue: | |
| Description: | Half-life(t1/2) of the drug |
| Measure: | Pharmacokinetics: CL |
| Time Frame: | Up to 30 days after last dose |
| Safety Issue: | |
| Description: | Total body clearance of the drug |
| Measure: | Pharmacokinetics: Vss |
| Time Frame: | Up to 30 days after last dose |
| Safety Issue: | |
| Description: | Volume of the distrubution at steady-state |
| Measure: | Immunogenicity |
| Time Frame: | Up to 30 days after last dose |
| Safety Issue: | |
| Description: | Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity |
| Measure: | Overall Response Rate (ORR） |
| Time Frame: | Up to 2 years after enrollment |
| Safety Issue: | |
| Description: | ORR includes CR and PR |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Zai Lab (Shanghai) Co., Ltd. |
Trial Keywords
- Advanced solid tumors or hematologic malignancies
Last Updated
July 28, 2021
