Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

Launched by SHANGHAI RUNSHI PHARMACEUTICAL TECHNOLOGY CO., LTD · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SYHA1813 for patients with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body. The trial aims to find out how safe and effective SYHA1813 is when used alone or in combination with other treatments. Participants will be grouped based on the type of tumor they have, and the study will look at the treatment's effects over time.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of advanced tumor confirmed by medical tests. They should also have at least one measurable tumor and be in relatively good health, with a life expectancy of at least three months. It's important to note that certain health conditions and recent treatments may exclude someone from participating. Participants can expect regular check-ups and monitoring throughout the study, and they will need to commit to using approved birth control methods during the trial. This is an exciting opportunity for patients seeking new treatment options, but it's essential to discuss all aspects of the trial with a healthcare provider before participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged \>= 18 years;
• 2. Unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology:
• • 3. There is at least one measurable lesion in the baseline period (RECIST1.1);
• • 4. ECOG PS of 0-1;
• • 5. The expected survival time is \>=3 months;
• 6. The organ function level and related laboratory indicators must meet the following requirements (No blood transfusion or hematopoietic stimulating factor therapy received within 14 days prior to the first medication (queue 1 to 6)/prior to randomization (queue 7 and queue 8):
• • ANC≥1.5×10\^9/L； PLT≥100×10\^9/L（Liver cancer patients PLT≥75×10\^9/L）； Hb≥90 g/L； TBIL≤1.5×ULN，and for Gilbert's syndrome, liver cancer or liver metastasis patients TBIL≤3×ULN； ALT和AST≤2.5×ULN，for liver cancer or liver metastasis patients ≤5×ULN； Child-Pugh Grade A (only applicable to queue 8)； ALB≥30 g/L； Cr≤1.5×ULN，IF Cr\>1.5×ULN，Ccr≥60 mL/min（Cockcroft-Gault）is required； APTT and INR≤1.5×ULN
• • 7. The subjects must agree to take medically approved contraceptive measures for at least 6 months from the beginning of the study to the last dose of drug.
• Exclusion Criteria:
• • 1. Patients who are known or suspected to be allergic to the test drug or its components;
• • 2. Excluding the disease studied in this trial, there are other primary malignant tumors that have progressed or require treatment within the past 3 years prior to screening (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured breast carcinoma in situ);
• • 3. The toxicity of previous anti-tumor treatments has not recovered (≤grode 1), except for hair loss and other adverse reactions judged by the investigator that do not affect the safety of the study medication;
• • 4. Active leptomeningeal disease or CNS metastases that are not well controlled;
• • 5. Uncontrollable active infections occurred within 14 days prior to the first medication (queue 1 to 6)/prior to randomization (queue 7 and queue 8), requiring systemic treatment with intravenous antibiotic infusion
• • 6. Patients with evidence of bleeding tendency or medical history within 28 days;
• • 7. Patients have risk factors for intestinal obstruction or intestinal perforation;
• • 8. The subject has poorly healed wounds, ulcers or fractures;
• • 9. Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;
• • 10. Patients have large pleural effusions, pericardial effusions, or abdominopelvic effusions;
• • 11. Human immunodeficiency virus (HIV) antibody positive; active hepatitis C, with antibody positive and HCV RNA test positive; active hepatitis B, with HBsAg positive, and HBV-DNA value\>500 IU/ml or 2500 copies/mL;
• • 12. Has a history of active tuberculosis;
• • 13. History of interstitial lung disease (except for radiotherapy-induced focal interstitial pneumonia), noninfectious pneumonitis requiring glucocorticoid therapy;
• • 14. Received immunosuppressants such as PD-1 or PD-L1 inhibitors in the recurrent or metastatic phase (only for Cohort 1);
• • 15. Prior treatment with a VEGFR-TKI inhibitor or other anti-angiogenic agent (except for Cohort 5,7,8);
• • 16. Pregnant or lactating women;
• • 17. Participants who may have poor compliance as judged by the investigator, such as a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current psychiatric disorders, psychotropic drug abuse, etc.;