- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407909
To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors
August 8, 2022 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
This is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the experimental drug(SYHX2001) in previously treated patients with advanced or metastatic cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of SYHX2001(name of the experimental drug) in patients with advanced or metastatic cancers who have exhausted standard treatment.
The study will consist of 2 parts, a dose escalation part and a cohort expansion part.
Once the recommended phase 2 dose (RP2D) has been determined in the dose escalation part, a cohort expansion part involving up to three separate cohorts will be conducted.
For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase.
An end-of-study visit will be conducted within 30 days after the last dose of SYHX2001.
Study Type
Interventional
Enrollment (Anticipated)
176
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaodong Wang
- Phone Number: +86 021-60673947
- Email: wang_xiaodong@mail.ecspc.com
Study Locations
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- Recruiting
- Harbin Medical University Cancer Hospital
-
Contact:
- Yanqiao Zhang, Professor
- Phone Number: 13845120210
- Email: yanqiaozhang@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients with an age of 18~75years (inclusive).
- Confirmed histologic or cytologic diagnosis of an advanced and/or metastatic solid tumor.
- At least one measurable lesion as defined by RECIST version 1.1.
- Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Life expectancy ≥3 months.
- Major organ function within 14 days prior to treatment meets the following criteria (no blood transfusion, Erythropoietin(EPO), Granulocyte Colony Stimulating Factor(G-CSF) or other medical support): Absolute Neutrophil Count(ANC)≥1.5×10^9/L,Platelet(PLT)≥90×10^9/L,Hemoglobin(Hb)≥100g/L or≥6.2 mmol/L;Creatinine(Cr)≤1.5×upper limit of normal(ULN) and creatinine clearance rate≥50mL/min;Total Bilirubin(TBIL)≤1.5×ULN; Prothrombin time(PT)≤1.5×ULN , Activated Partial Thromboplastin Time(APTT)≤1.5×ULN , Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT)≤2.5 × ULN.
- Signed informed consent form.
Exclusion Criteria:
- Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks prior to the first dose of the study drug, or administration of other investigational agents within 4 weeks or 5 half-lives prior to the first dose of the study drug, whichever is longer.
- Major surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
- Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0。
- Have a history of severe cardiovascular and cerebrovascular disease.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled and not suitable for the study according to the judgment of the investigator.
- Known history of hypersensitivity to test drug components.
- Patients with recent active bleeding or a history of bleeding.
- Those with coagulation disorders or taking thrombolytic, anticoagulant or antiplatelet agglutination drugs.
- Gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess within 6 months prior to first dose; or currently under investigator's judgement there are high risk factors for hollow organ perforation/fistula formation).
- Inability to swallow the drug orally, or a condition that seriously affects gastrointestinal absorption in the judgment of the investigator.
- Irritable bowel syndrome with signs/symptoms requiring medication.
- Persistent active diarrhea requiring medical treatment.
- Concomitant use of strong CYP3A4 inhibitors or inducers, strong CYP2D6 inhibitors and strong P-gp inhibitors within 14 days prior to the first dose of the study drug.
- History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
- Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or other active viral infection.
- Male and female patients of childbearing potential do not agree to use suitable method of contraception during the treatment and 6 months after the last dose of study medication; female patients do not have negative results of serum/urine pregnancy test within 7 days prior to enrollment and would be breastfeeding.
- Not suitable for this study as determined by the investigator due to other reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SYHX2001
SYHX2001 will be administered orally.
|
SYHX2001 tablets, oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicities (DLT) in stage Ⅰ
Time Frame: Baseline through Day 28
|
Baseline through Day 28
|
Maximum tolerated dose (MTD) in stage Ⅰ
Time Frame: Baseline through Day 28
|
Baseline through Day 28
|
Recommended phase 2 dose (RP2D)
Time Frame: Baseline through approximately 2 years
|
Baseline through approximately 2 years
|
Incidence and severity of adverse events in stage Ⅰ
Time Frame: Baseline through approximately 2 years
|
Baseline through approximately 2 years
|
Overall response rate (ORR) in stage Ⅱ
Time Frame: Up to approximately 2 years
|
Up to approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed plasma concentration (Cmax) of SYHX2001
Time Frame: Baseline and up to approximately 2 years
|
Baseline and up to approximately 2 years
|
|
Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) of SYHX2001
Time Frame: up to approximately 2 years
|
up to approximately 2 years
|
|
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of SYHX2001
Time Frame: up to approximately 2 years
|
up to approximately 2 years
|
|
Terminal phase half-life (t1/2) of SYHX2001
Time Frame: up to approximately 2 years
|
up to approximately 2 years
|
|
Oral clearance (CL/F) of SYHX2001
Time Frame: up to approximately 2 years
|
up to approximately 2 years
|
|
PFS Progression-free survival (PFS)
Time Frame: up to approximately 2 years
|
PFS is defined as the time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.
|
up to approximately 2 years
|
Duration of Response (DOR)
Time Frame: up to approximately 2 years
|
DOR is defined as the time from first evidence of response (complete response or partial response per RECIST 1.1) to earlier date of disease progression or death due to any cause.
|
up to approximately 2 years
|
Number of patients with any adverse events(AEs) and serious adverse events(SAEs) in stage Ⅱ
Time Frame: up to approximately 2 years
|
up to approximately 2 years
|
|
Change from Baseline in symmetrical arginine dimethylation (SDMA) as a pharmacodynamics(PD) measure
Time Frame: Baseline and up to approximately 2 years
|
Baseline and up to approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2022
Primary Completion (Anticipated)
January 6, 2026
Study Completion (Anticipated)
January 6, 2026
Study Registration Dates
First Submitted
May 30, 2022
First Submitted That Met QC Criteria
June 3, 2022
First Posted (Actual)
June 7, 2022
Study Record Updates
Last Update Posted (Actual)
August 9, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYHX2001C101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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