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A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

A Phase I Open and Multiple Ascending Dose Study to Assess the Safety、Tolerability、Pharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours

NCT03658070•Shijiazhuang Yiling Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet all of the following criteria before entering the group:
•1. Patients with advanced/metastatic solid tumor (such as non-small cell lung cancer, gastrointestinal stromal tumor, renal cell carcinoma, pancreatic cancer, etc.) who have failed standard treatment with histological or cytological diagnosis, have no effective treatment, or have relapsed after treatment.
•2. Patients with measurable or evaluable tumor lesions (1.1 version of RECIST efficacy evaluation criteria).
•3. The age is 18\~70 years old (including upper and lower limit), and there is no restriction on male and female (for participating in the extended trial)Of patients with a sex ratio of not less than 30%).
•4. Physical condition ECOG≤2.
•5. Expected survival ≥3 months.
•6. BMI at 19≤BMI≤30, BMI = weight (kg)/height 2 (m2).
•7. Liver function: AST \<2.5×ULN, ALT\<2.5×ULN, total bilirubin \<1.5×ULN.
•8. Blood biochemistry: Serum potassium and sodium levels are within the range of normal laboratory values (if researchers and physiciansThe overseer assesses results beyond the normal range to be of no clinical significance and the patient canInto the group; If the drug can be controlled within the normal range during the screening period, the patient canTo enroll).
•9. Renal function: serum creatinine (Scr) ≤1.5×ULN or calculated creatinine clearance rate(Ccr) \>60mL/min Ccr calculation formula: male Ccr=\[(140- age)× weight(kg)\] / \[0.818 x Scr (mu mol/L)\], women Ccr = 0.85 x \[(140 - age) by weight(kg)\] / \[0.818 x Scr (mu mol/L)\].
+6 more criteria

Exclusion Criteria

•Patients cannot participate in this clinical study if they meet any of the following conditions:
•1. Pregnant or lactating women.
•2. Tested positive for human immunodeficiency virus (HIV).
•3. The active period of HBV or HCV infection is known to be associated with abnormal liver function, and antiviral drugs are required.
•4. Severe trauma, ulcer or fracture at screening time.
•5. A history of uncontrolled epilepsy, central nervous system disease or mental illness.
•6. Symptomatic or uncontrolled brain metastases or meningeal diseases.
•7. diabetes or hypertension with poor drug control (under optimal drug treatment, fasting blood glucose \>7mmol/L, or blood pressure \> 150/100mmhg).
•8. Uncontrolled thyroid dysfunction.
•9. Persistent arrhythmias of version 4.03 or above, NCI CTCAE level ≥2, atrial fibrillation of any level.
+8 more criteria

Locations (4)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Hainan Medical College

Haikou, Hainan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

December 19, 2018

Primary Completion Date

December 1, 2020

Completion Date

December 1, 2020

Last Updated

August 21, 2020

Enrollment

ESTIMATED participants

Conditions

Advanced or Metastatic Solid Tumours

Interventions

XY0206

DRUG

Contacts

wei wang, master

CONTACT

086-0311-66703017 wangwei001@yiling.cn

A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer

NCT03548467

Locally Advanced or Metastatic Solid Tumours

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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