Advanced Cancer
Conditions
Keywords
Advanced solid tumors or hematologic malignancies
Brief summary
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.
Interventions
DRUGZL-1201
Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events | From the time of informed consent to 30 days after last dose | Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Cmax | Up to 30 days after last dose | Maximum serum concentration(Cmax) of the drug after the administration |
| Pharmacokinetics: t1/2 | Up to 30 days after last dose | Half-life(t1/2) of the drug |
| Pharmacokinetics: CL | Up to 30 days after last dose | Total body clearance of the drug |
| Pharmacokinetics：AUC | Up to 30 days after last dose | The area under the curve (AUC) of serum concentration of the drug after the administration |
| Immunogenicity | Up to 30 days after last dose | Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity |
| Overall Response Rate (ORR） | Up to 2 years after enrollment | ORR includes CR and PR |
| Pharmacokinetics: Vss | Up to 30 days after last dose | Volume of the distrubution at steady-state |
Countries
China, United States
Outcome results
None listed