Overview
First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer
Description
This is a first-in-human, dose escalation trial of an anti-CD47 antibody. 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. This study The study is composed of 3 stages: Part 1 low dose group, and Part 2 high dose group. Part 3 pharmacodynamic (PD)/ dose expansion cohort will open after the completion of Part 1 and 2.
Eligibility
Inclusion Criteria:
- Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma
- Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment.
- Adequate hematologic status
- Adequate coagulation function
- Adequate hepatic function
- Adequate renal function
Exclusion Criteria:
- Known primary tumors of central nervous system disease
- Known active brain metastases
- Red blood cells transfusion dependence
- Known cardiopulmonary disease
- Pregnant or breast-feeding females
- Any other serious underlying medical