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A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours

NCT03658070 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-08-21

No results posted yet for this study

Summary

1. To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans.
2. To investigate the pharmacokinetic (PK) characteristics, pharmacodynamics (PD) characteristics, and PK/PD correlation of single and multiple doses of XY0206 in patients with advanced/metastatic malignant solid tumors to provide dose selection basis for clinical studies;
3. To evaluate the effect of standard meal on main PK parameters of XY0206;
4. To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor.
5. To explore the correlation between PK and QTcF.
6. Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.

Conditions

  • Advanced or Metastatic Solid Tumours

Interventions

DRUG

XY0206

Dosage form:Tablet;Single dose treatment:Take the drug once on day 1,each time 1 tablet. Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the criteria for stopping treatment or determine the duration and interval of treatment according to the accumulated condition after multiple dose.

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Binghe Xu, MD · Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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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 NCT03658070 on ClinicalTrials.gov