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Tests treatment safety and results for Advanced Cancer
Official title A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06736275
What this study is testing
What is SXRN?
SXRN is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for advanced cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- For Dose-Escalation Phase:
- male or female, aged 18\~75 at the time of signing the ICF;
- patient with advanced solid tumors who have failed/cannot tolerate previous standard therapies or lack conventional effective therapies;
- at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
You likely can't join if
- people who meet any of the criteria below must not be included:
- has received any of the anti-tumor treatments below:a) received cytotoxic chemotherapy, tumor immunotherapy, anti-tumor biologics or other trail...
- participated in and received an investigational drug or device clinical trial within 4 weeks before initial infusion.
- Patients who had undergone or planned to undergo major surgery or treatment therapy (excluding tumor biopsy, puncture, etc.) within 4 weeks before...
- unrecovered from the toxic reaction caused by previous anti-tumor treatment (not recovered to ≤ grade 1 or baseline; not including toxic reactions...
- with clinically uncontrollable serous effusion (pleural effusion, ascites and pericardio effusion). Conditions may include: moderate or above sized...
See the full eligibility criteria
Who can join
- For Dose-Escalation Phase:
- male or female, aged 18\~75 at the time of signing the ICF;
- patient with advanced solid tumors who have failed/cannot tolerate previous standard therapies or lack conventional effective therapies;
- at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- expected survival time ≥12 weeks;
- lab results and organ function tested within 7 days before the initial infusion meet the criteria below:
- Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L;2)Platlets (PLT) Count≥90×10\^9/L; 3)Hemoglobins (Hb) ≥90 g/L. Note: the criteria above shall still be maintained within 14 days before the initial infusion...
- Blood biochemistry: 1)Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); 2)Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft Gault formula ≥50 mL/min; 3)Aspartate Amino Transferase...
- Urine protein ≤2+ (if \>2+, urine protein shall be collected for 24 hours; total protein ≤1g is acceptable for inclusion).
- International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Note: for people receiving precautious anti-coagulation treatment, the investigator shall determine...
- Left Ventricular Ejection Fraction (LVEF) ≥50%.
- can understand and voluntarily sign the Informed Consent Form (ICF); must be voluntary and able to finish the study program and follow-up tests.
What rules you out
- people who meet any of the criteria below must not be included:
- has received any of the anti-tumor treatments below:a) received cytotoxic chemotherapy, tumor immunotherapy, anti-tumor biologics or other trail agents within 4 weeks or 5 half-times (whichever is shorter) before the...
- participated in and received an investigational drug or device clinical trial within 4 weeks before initial infusion.
- Patients who had undergone or planned to undergo major surgery or treatment therapy (excluding tumor biopsy, puncture, etc.) within 4 weeks before initial infusion.
- unrecovered from the toxic reaction caused by previous anti-tumor treatment (not recovered to ≤ grade 1 or baseline; not including toxic reactions with no safety risk as determined by the investigator, such as alopecia...
- with clinically uncontrollable serous effusion (pleural effusion, ascites and pericardio effusion). Conditions may include: moderate or above sized effusion, received within 2 weeks before the selection or plans to...
- with central nervous system metastasis and show relating symptoms.
- with a history of other malignant tumors, except for those that have received radical surgery and not relapsed 5 years thereafter, such as carcinoma in situ of cervix, skin basal cell carcinoma, and etc.
- with a history of immune deficiency diseases, including acquired or congenital immunodeficiency disorders; or a history of organ transplantation, heterogeneous bone marrow transplantation, or autologous hematopoietic...
- had (non-infectious) lung inflammation / interstitial lung disease that required steroid treatment within 4 weeks before the initial infusion.
- with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- severe abnormalty in cardiac rhythm or conduction, such as ventricular arrhythmia requiring clinical intervention, atrioventricular block of II\~III grade, and etc.;
- cardiac insufficiency of III\~IV grade as defined by New York Heart Association(NYHA);
- acute coronary syndrome, congestive cardiac failure, aortic dissection, cerebral stroke or other grade 3 or above cardio-cerebral vascular events within 6 months before the initial infusion.
- with uncontrollable high blood pressure (systolic pressure ≥160 mmHg and/or diastolic pressure ≥100 mmHg) after treatment with anti-hypertensive drugs of stable doses.
- with active chronic hepatitis B (such as, HbsAg or HbcAb positive and HBV DNA ≥ lower limit of detection, active hepatisis C (such as, HCV antibody positive and HCV RNA≥ lower limit of detection), or HIV infection.
- with active infections within 2 weeks before the initial infusion that require systematic treatment.
- with a history of active tuberculosis infection within 1 year before the initial infusion.
- had or has uncontrollable or serious diseases that may interfere with the participation or evaluation in the study, as considered by the investigator;
- known to be allergic or taking drugs contradictionary to the study drug (Suplussirna) or its excipients.
- premenopause female candidates (postmenopausal female patients can only be considered infertilewhen they have been postmenopausal for at least 12 months) with positive results in serum pregnancy test; candidates of...
- other conditions that are determined by the investigator as unsitable for entering this trial. For Expansion Cohort(assigned by chance, blinded, compared with an inactive treatment Part):
- Inclusion Criteria:
- Male or female, aged 18 to 75 years at time of signing ICF.
- Histologically or cytologically confirmed solid tumor.
- Patients who have failed standard therapy, lack standard therapy, or are in a treatment holiday period (4 weeks) without need for anti-tumor therapy.
- Diagnosis of cancer anorexia-cachexia according to 2025 CSCO guideline, meeting either (①+②) or (①+③):
- Involuntary weight loss \>5% in 6 months; OR weight loss \>2% with BMI \ 2% with reduced muscle mass.
- Anorexia (VAS ≤70 or FAACT-A/CS-12 score ≤37).
- CRP \>5 mg/L.
- ECOG performance status 0-2.
- Life expectancy ≥12 weeks.
- Adequate organ function and laboratory parameters within 7 days prior to first study drug, meeting the same criteria as listed above for the dose-escalation phase (i.e., ANC, platelets, hemoglobin, liver/kidney...
- Same informed consent requirement as the dose-escalation phase: able to understand and voluntarily sign the ICF, and willing/able to complete study procedures and follow-up. Exclusion Criteria: The exclusion criteria...
- Reversible causes of reduced food intake determined by investigator (e.g., mechanical obstruction preventing eating).
- Use of any medication or therapy for cachexia, anorexia, or weight loss (excluding enteral nutrition support) within 28 days or 5 half-lives (whichever shorter) prior to first study drug, including but not limited to...
- Currently receiving tube feeding or parenteral nutrition.
- Cachexia clearly due to other causes (e.g., severe COPD, AIDS).
- Hormone therapy judged by investigator to improve cachexia.
- Central nervous system metastases requiring intervention (instead of "symptomatic CNS metastases").
- Known allergy or contraindication to SXRN or its process impurities (e.g., spectinomycin).
- Note: For the expansion cohort, the washout period for other investigational drugs is "4 weeks or 5 half-lives" (same as dose-escalation phase), and all other exclusion criteria (prior anti-tumor treatments, unresolved...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.