Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors
NCT04450901 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2022-12-05
Summary
This is a Phase 1/2a, open-label, multicenter, dose-escalation/dose-expansion study of YBL-006, in participants with Advanced Solid Tumors. This multicenter study will be conducted in approximately 11-14 participants in the dose escalation phase, and approximately 39-76 participants in dose expansion phase.
Conditions
Interventions
- DRUG
-
YBL-006
Route of Administration: IV infusion; 0.5 mg/kg Q2W
- DRUG
-
YBL-006
Route of Administration: IV infusion; 2 mg/kg Q2W
- DRUG
-
YBL-006
Route of Administration: IV infusion; 5 mg/kg Q2W
- DRUG
-
YBL-006
Route of Administration: IV infusion; 10 mg/kg Q2W
- DRUG
-
YBL-006
Route of administration : IV infusion, 200 mg Q2W
- DRUG
-
YBL-006
Route of administration : IV infusion, 300 mg Q3W
- DRUG
-
YBL-006
Route of administration : IV infusion, 300 mg Q2W
- DRUG
-
YBL-006
Route of administration : IV infusion, 200mg Q2W
Sponsors & Collaborators
-
Novotech (Australia) Pty Limited
collaborator INDUSTRY -
Y Biologics Inc.
lead INDUSTRY
Principal Investigators
-
Yoon Jaebong · Y-Biologics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-01
- Primary Completion
- 2023-03-31
- Completion
- 2023-03-31
Countries
- Australia
- South Korea
- Thailand
Study Locations
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