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To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors

Primary Purpose

Advanced or Metastatic Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SYHX2001
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Solid Tumors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients with an age of 18~75years (inclusive).
  2. Confirmed histologic or cytologic diagnosis of an advanced and/or metastatic solid tumor.
  3. At least one measurable lesion as defined by RECIST version 1.1.
  4. Eastern Cooperative Oncology Group Performance Status 0 or 1.
  5. Life expectancy ≥3 months.
  6. 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.
  7. Signed informed consent form.

Exclusion Criteria:

  1. 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.
  2. Major surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
  3. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0。
  4. Have a history of severe cardiovascular and cerebrovascular disease.
  5. 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.
  6. Known history of hypersensitivity to test drug components.
  7. Patients with recent active bleeding or a history of bleeding.
  8. Those with coagulation disorders or taking thrombolytic, anticoagulant or antiplatelet agglutination drugs.
  9. 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).
  10. Inability to swallow the drug orally, or a condition that seriously affects gastrointestinal absorption in the judgment of the investigator.
  11. Irritable bowel syndrome with signs/symptoms requiring medication.
  12. Persistent active diarrhea requiring medical treatment.
  13. 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.
  14. History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
  15. Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or other active viral infection.
  16. 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.
  17. Not suitable for this study as determined by the investigator due to other reasons.

Sites / Locations

  • Harbin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SYHX2001

Arm Description

SYHX2001 will be administered orally.

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLT) in stage Ⅰ
Maximum tolerated dose (MTD) in stage Ⅰ
Recommended phase 2 dose (RP2D)
Incidence and severity of adverse events in stage Ⅰ
Overall response rate (ORR) in stage Ⅱ

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) of SYHX2001
Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) of SYHX2001
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of SYHX2001
Terminal phase half-life (t1/2) of SYHX2001
Oral clearance (CL/F) of SYHX2001
PFS Progression-free survival (PFS)
PFS is defined as the time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.
Duration of Response (DOR)
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.
Number of patients with any adverse events(AEs) and serious adverse events(SAEs) in stage Ⅱ
Change from Baseline in symmetrical arginine dimethylation (SDMA) as a pharmacodynamics(PD) measure

Full Information

First Posted
May 30, 2022
Last Updated
August 8, 2022
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05407909
Brief Title
To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors
Official Title
To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
January 6, 2026 (Anticipated)
Study Completion Date
January 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SYHX2001
Arm Type
Experimental
Arm Description
SYHX2001 will be administered orally.
Intervention Type
Drug
Intervention Name(s)
SYHX2001
Intervention Description
SYHX2001 tablets, oral
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLT) in stage Ⅰ
Time Frame
Baseline through Day 28
Title
Maximum tolerated dose (MTD) in stage Ⅰ
Time Frame
Baseline through Day 28
Title
Recommended phase 2 dose (RP2D)
Time Frame
Baseline through approximately 2 years
Title
Incidence and severity of adverse events in stage Ⅰ
Time Frame
Baseline through approximately 2 years
Title
Overall response rate (ORR) in stage Ⅱ
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of SYHX2001
Time Frame
Baseline and up to approximately 2 years
Title
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
Title
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of SYHX2001
Time Frame
up to approximately 2 years
Title
Terminal phase half-life (t1/2) of SYHX2001
Time Frame
up to approximately 2 years
Title
Oral clearance (CL/F) of SYHX2001
Time Frame
up to approximately 2 years
Title
PFS Progression-free survival (PFS)
Description
PFS is defined as the time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.
Time Frame
up to approximately 2 years
Title
Duration of Response (DOR)
Description
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.
Time Frame
up to approximately 2 years
Title
Number of patients with any adverse events(AEs) and serious adverse events(SAEs) in stage Ⅱ
Time Frame
up to approximately 2 years
Title
Change from Baseline in symmetrical arginine dimethylation (SDMA) as a pharmacodynamics(PD) measure
Time Frame
Baseline and up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Wang
Phone
+86 021-60673947
Email
wang_xiaodong@mail.ecspc.com
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqiao Zhang, Professor
Phone
13845120210
Email
yanqiaozhang@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors

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