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

Launched by CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY CO., LTD. · Jun 3, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new drug called SYHX2001 to see if it is safe and tolerable for patients with advanced or metastatic solid tumors, which are types of cancer that have spread beyond their original site. The study is currently looking for participants who are between 18 and 75 years old and have a confirmed diagnosis of these cancers. To be eligible, patients should have at least one measurable tumor, be in decent health, and have a life expectancy of at least three months. Importantly, they should not have received certain cancer treatments or surgeries in the four weeks before starting the trial.

Participants in this trial can expect to take the experimental drug and undergo regular check-ups to monitor their health and how their body responds to the treatment. The study is designed to provide valuable information on how the drug works and its effects on patients. If you or a loved one are considering joining this trial, it’s essential to discuss any health conditions and medications with the study team to ensure eligibility and safety.

Gender

ALL

Eligibility criteria

• 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.