First in Human Dose Escalation Study of YL-13027 in Subjects With Advanced Stage Solid Tumors
NCT03869632 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2021-11-16
Summary
YL-13027-001 is a phase I open-label, first in human, dose escalation study which investigate the tolerability, safety, pharmacokinetics (PK) and efficacy of YL-13027 in subjects with advanced stage solid tumors.
Conditions
Interventions
- DRUG
-
YL-13027
Daily doses by oral administration on each day of each 28 day cycle. Starting dose is 60mg, with escalation to 360mg, and subsequent dose escalation using a modified Fibonacci algorithm.
Sponsors & Collaborators
-
Shanghai YingLi Pharmaceutical Co. Ltd.
lead INDUSTRY
Principal Investigators
-
Hanying Bao, PhD · Shanghai YingLi Pharmaceutical Co. Ltd.
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
- 2019-03-19
- Primary Completion
- 2021-04-30
- Completion
- 2022-06-30
Countries
- China
Study Locations
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