A Study of ICP-192 in Patients With Advanced Solid Tumors
NCT04565275 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2023-03-14
Summary
This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.
Conditions
Interventions
- DRUG
-
Drug ICP-192
1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme 2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.
Sponsors & Collaborators
-
Beijing InnoCare Pharma Tech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2023-11-30
- Completion
- 2024-04-15
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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