A Trial of ZL-1201 in Subjects With Advanced Cancer

Study Overview
=================
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.

Official Title
-----------------
First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: ZL-1201


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm, ZL-1201<br>Single arm, ZL-1201 | Drug: ZL-1201<br>* Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.<br>* Other names: Monotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced solid tumors or hematologic malignancies