Safety of PUR001 Monotherapy in Patients With Advanced Solid Tumors
NCT05234853 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2023-01-20
Summary
This is a Phase I, First-In-Human, open label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of PUR001, an anti-CD39 monoclonal antibody, in adult patients with advanced solid tumors, as monotherapy. A "3+3" design will be used to determine MTD and RP2D. .
Conditions
Interventions
- DRUG
-
PUR001
Monoclonal antibody
Sponsors & Collaborators
-
Purinomia Biotech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Development · Purinomia Biotech, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-28
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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