A Trial of ZL-1201 in Subjects With Advanced Cancer

Zai Lab

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: ZL-1201

Study type: Interventional

Funder types: Industry

Identifiers

NCT04257617

ZL-1201-001

Details and patient eligibility

About

First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Single arm, ZL-1201

Experimental group

Description:

Single arm, ZL-1201

Treatment:

Drug: ZL-1201