A Trial of ZL-1201 in Subjects With Advanced Cancer

Zai Lab (Shanghai) Co., Ltd.37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer

Interventions

ZL-1201DRUG

Part 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

US2004

Phoenix, Arizona, United States

US2005

Jacksonville, Florida, United States

US2001

Rochester, Minnesota, United States

US2003

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: From the time of informed consent to 30 days after last dose