Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors
NCT06001684 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-01-03
Summary
This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.
Conditions
Interventions
- BIOLOGICAL
-
IBR854 Cell Injection
The minimum initial dose is 3.0×10\^9 cells and then escalate to 5.0×10\^9 cells and 7.0×10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.
Sponsors & Collaborators
-
Imbioray (Hangzhou) Biomedicine Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Ning Li, MD, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2024-09-30
- Completion
- 2024-12-30
Countries
- China
Study Locations
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