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

NCT05407909 | Unknown Phase 1

• 1 other identifier: SYHX2001C101
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Dose limiting toxicities (DLT) in stage Ⅰ

  Baseline through Day 28

• Maximum tolerated dose (MTD) in stage Ⅰ

  Baseline through Day 28

• Recommended phase 2 dose (RP2D)

  Baseline through approximately 2 years

• Incidence and severity of adverse events in stage Ⅰ

  Baseline through approximately 2 years

• Overall response rate (ORR) in stage Ⅱ

  Up to approximately 2 years

Secondary Outcomes (9)

• Maximum observed plasma concentration (Cmax) of SYHX2001

  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

  up to approximately 2 years

• AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of SYHX2001

  up to approximately 2 years

• Terminal phase half-life (t1/2) of SYHX2001

  up to approximately 2 years

• Oral clearance (CL/F) of SYHX2001

  up to approximately 2 years

Study Arms (1)

SYHX2001

EXPERIMENTAL

SYHX2001 will be administered orally.

Drug: SYHX2001

Interventions

SYHX2001 DRUG

SYHX2001 tablets, oral

SYHX2001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Central Study Contacts

Xiaodong Wang

CONTACT

+86 021-60673947; wang_xiaodong@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: July 27, 2022
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

CN (1)