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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869632 on ClinicalTrials.gov