Status unknownNCT03658070Updated Aug 21, 2020

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

A Phase 1 interventional study of XY0206 in Advanced or Metastatic Solid Tumours, sponsored by Shijiazhuang Yiling Pharmaceutical Co. Ltd. Status unknown at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by Shijiazhuang Yiling Pharmaceutical Co. Ltd · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 34
Allocation: Non-randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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.
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;
To evaluate the effect of standard meal on main PK parameters of XY0206;
To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor.
To explore the correlation between PK and QTcF.
Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.

Conditions studied

Advanced or Metastatic Solid Tumours

Browse trials for

Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 34 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Shijiazhuang Yiling Pharmaceutical Co. Ltd is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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)].
10. blood routine: platelet count of > 80×109/L, hemoglobin of > 90g/L, neutrophil pair count of > 1.5×109 /L.
11. Urine routine: urinary protein - or 1+, or 24-hour urinary protein \<1 g [Note: if due to urinary tractTransient abnormalities of the above urinary protein due to infection and other causes returned to normal after retesting.You can also consider enrolling; Subjects without proteinuria symptoms may also be considered for inclusion.
12. Coagulation function: International standardized ratio \< 1.5.
13. No other antitumor concomitant therapy (including steroids with antitumor effects).
14. Women of childbearing age and men agreed to use it throughout the study period and within 6 months after completion of treatmentRegular contraception that is effective enough.
15. Understand and voluntarily sign written informed consent, and have the willingness and ability to complete regular visits and treatmentTreatment planning, laboratory examination and other test procedures.

Exclusion 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.
10. Cardiac ejection fraction (ECHOcardiography) below 50%.
11. patients with clinically significant prolonged history of QTc (>450ms for male and >470ms for female).
12. Have a history of severe drug allergy (NCI CTCAE level ≥3 according to version 4.03 or above) and may be allergic to test drug ingredients; Has been treated with or is allergic to sunitinib malate.
13. for the first time to give medicine taken within 4 weeks before have significant effects on P450 metabolic pathway of drugs (for example: ketoconazole, itraconazole, clarithromycin, aza that wei, indiana that wei, naphthalene sanzuotong, that of the wei and the wey, ShaKui the wey, terry toxin, voriconazole, dexamethasone, phenytoin, carbamazepine, rifampicin, dean, rifampicin and dean at the cloth, phenobarbital, st. John's wort, etc.) or to eat within 48 h before delivery of P450 metabolic enzyme pathways have a significant impact on food (such as grapefruit and food containing grapefruit).
14. Received any experimental drug therapy within 6 weeks prior to initial administration.
15. for the first time six weeks before the treatment, patients treated with anti-tumor therapy (chemotherapy, radiation therapy, biological therapy, or hormone therapy) (note: for anti-tumor small molecules targeting drugs, if the patient before the first test drugs, always use small molecules targeting drug has cleared more than 5 half-life, the patient may also be considered into the group]. Surgery was performed within 14 weeks prior to the first administration.
16. patients have any limit test compliance of medical or psychiatric conditions, such as the central nervous system (CNS) leukemia, active control of bacterial infection, 3, or 4 bleeding, unstable angina, myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, or into the group of six months before the test of catheter-related deep vein thrombosis, insulin-dependent diabetes mellitus (namely, type 1 diabetes), or non insulin-dependent diabetes but there were signs of small vascular disease, Adrenocortical dysfunction is known, malabsorption syndrome is known, and active autoimmune diseases are known.
17. Other severe acute or chronic medical or psychiatric conditions, or laboratory test abnormalities that may exacerbate the risks associated with participating in or taking test drugs, or that may interfere with the interpretation of test results. These conditions or abnormalities may be determined by the investigator to make the patient unfit to participate in the trial.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 34 participants (estimated)

Study arms

Experimental
XY0206-12.5mg
Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg;Include single dose treatment and multiple dose phase
Drug: XY0206
Experimental
XY0206-25mg
Drug:XY0206;Dosage form:Tablet;Dosage：25mg;Include single dose treatment and multiple dose phase
Drug: XY0206
Experimental
XY0206-37.5mg
Drug:XY0206;Dosage form:Tablet;Dosage：37.5mg;Include single dose treatment and multiple dose phase
Drug: XY0206
Experimental
XY0206-50mg
Drug:XY0206;Dosage form:Tablet;Dosage：50mg;Include single dose treatment and multiple dose phase
Drug: XY0206
Experimental
XY0206-75mg
Drug:XY0206;Dosage form:Tablet;Dosage：75mg;Include single dose treatment and multiple dose phase
Drug: XY0206
Experimental
XY0206-100mg
Drug:XY0206;Dosage form:Tablet;Dosage：100mg;Include single dose treatment and multiple dose phase
Drug: XY0206

Interventions

DrugXY0206
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.

What researchers measure

Primary outcomes

DLT
The occurrence of DLT.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
AE
The occurrence rate of AE.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
ADR
The occurrence rate of adverse drug reactions(ADR).
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
SAE
The occurrence rate of SAE.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood routine
One of the laboratory tests.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Urine routine
One of the laboratory tests.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Stool routine
One of the laboratory tests.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood biochemistry
One of the laboratory tests.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Coagulation function
One of the laboratory tests.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
12 lead ecg
One of the laboratory tests.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Body temperature
One of the vital signs.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood pressure
One of the vital signs.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Heart rate
One of the vital signs.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Breathing
One of the vital signs.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
General condition
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Skin
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Head
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Eyes
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Ears
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Nose
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Throat
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Heart
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Lung
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Chest
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Abdomen
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Limbs
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Nerves
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Back/spine
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Lymph nodes
One of the physical examination.
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication

Secondary outcomes

AUCinf
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
AUC0-24h
area under the concentration-time curve from the time of dosing extrapolated to the 24h after dosing.
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
AUC0-72h
area under the concentration-time curve from the time of dosing extrapolated to the 72h after dosing.
Time frame: single dose phase:up to 72 hours
AUC0-120h
area under the concentration-time curve from the time of dosing extrapolated to the 120h after dosing.
Time frame: single dose phase:up to 120 hours
Peak Plasma Concentration (Cmax)
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
CL/F
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Tmax
The amount of time that a drug is present at the maximum concentration in serum.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cmin,ss
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cmax,ss
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cav,ss
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
PTF
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RAUC1
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RAUC2
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RCmax
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Kel
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
t1/2
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Vz/F
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
AUC_%Extrap
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Ae0-24h
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Fe0-24h
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Ae0-72h
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 72 hours
Fe0-72h
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 72 hours
Ae0-72h stool
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 72 hours
CLr
The PK parameters of the plasma sample.
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Exploring the relative baseline change percentage of biomarkers (soluble VEGFR2).
The PD parameters of XY0206.
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Complete response rate (CRR)
Effective parameters of XY0206.
Time frame: through study completion,such as 30 months.
Partial response rate (PRR)
Effective parameters of XY0206.
Time frame: through study completion,such as 30 months.
Objective response rate (ORR)
Effective parameters of XY0206.
Time frame: through study completion,such as 30 months.
Progression-free survival (PFS)
Effective parameters of XY0206.
Time frame: through study completion,such as 30 months.

Study locations

1 of 4 sites recruiting

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing 100021, China
- binghe xu, MD · Contact · xubinghe@medmail.com.cn · 086-010-87788826
- binghe xu, MD · Principal investigator
Recruiting
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan 570102, China
- Jinsheng Wu, MD · Contact · wjs7911@126.com · 086-13707599070
Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000, China
- Da Jiang, MD · Contact · jiangda139@163.com · 086-13933191980
Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin 300060, China
- Zhanyu Pan, MD · Contact · tjpanzhanyu@medmail.com.cn · 086-13820583299
Not yet recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03658070
Lead sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd
Collaborators: Tigermed Consulting Co., Ltd
Responsible party: Sponsor
First posted: Sep 5, 2018
Start date: Dec 19, 2018
Primary completion: Dec 2020 (estimated)
Completion: Dec 2020 (estimated)
Last update: Aug 21, 2020

Study contacts

wei wang, master

Contact

wangwei001@yiling.cn

086-0311-66703017

Binghe Xu, MD

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

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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