Evaluating SYHX2001 for patients with advanced or metastatic solid tumors

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

This study is testing a new drug called SYHX2001 to see if it is safe and helps people with advanced or metastatic solid tumors who have already tried other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT05407909 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, multicenter study aims to assess the safety and tolerability of SYHX2001 in patients with advanced or metastatic solid tumors who have already undergone standard treatments. The study consists of two parts: a dose escalation phase to determine the recommended phase 2 dose (RP2D) and a cohort expansion phase involving multiple groups of patients. Participants will undergo screening, treatment, and post-treatment follow-up phases, with evaluations of pharmacokinetics and pharmacodynamics of the drug. The study is designed to gather critical data on the drug's effects and safety profile in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed advanced or metastatic solid tumors and measurable lesions.

Not a fit: Patients who have not exhausted standard treatment options or have other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced or metastatic solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar dose escalation approaches in advanced cancer treatments, but the specific drug SYHX2001 is novel.

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.

Where this trial is running

Harbin, Heilongjiang

• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaodong Wang

Conditions Advanced or Metastatic Solid Tumors