Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
NCT03544905 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2025-04-22
Summary
This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
Conditions
Interventions
- DRUG
-
CYH33 for tablet
1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)
Sponsors & Collaborators
-
Haihe Biopharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Ruihua Xu, M.D · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-05
- Primary Completion
- 2024-12-04
- Completion
- 2024-12-04
Countries
- China
Study Locations
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