Advanced CancerEarly Phase 1NCT06736275
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
A Early Phase 1 study testing SXRN in people with Advanced Cancer and Cachexia, run by Jiangsu Nutai Biologics Co., Ltd at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer, Cachexia
- What is being tested?
- SXRN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to 9 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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, either without the need of blood transfusion, or using supportive treatment including granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11 (IL-11), and erythropoietin (EPO), and etc.
- 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 (AST), Alanine Aminotransferase (ALT) ≤2.5×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g/L.
- 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 subjects receiving precautious anti-coagulation treatment, the investigator shall determine whether INR and APTT remains in a safe and effective range for treatment.
- 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.
- 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 <18.5 kg/m²; OR weight loss >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 function, coagulation, LVEF, etc.).
- 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.
Who cannot join
- Subjects 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 initial infusion.b)received an oral small-molecule targeted anti-tumor agent within 2 weeks before the first infusion or for five half-lives(whichever was shorter).c) received anti-tumor Chinese patent medicine approved by NMPA within 2 weeks before the initial infusion.d) received more than 30% bone marrow radiotherapy or large area radiotherapy within 2 weeks before initial infusion (palliative radiotherapy at the bone or superficial lesions is acceptable).
- 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 interventional 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, asymptomatic hypothyroidism caused by immune checkpoint inhibitors that can be treated with only thyroid hormone and remains stable, and etc.).
- 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 receive local treatments (including drainage, peritoneal shunt, and cell-free concentrated ascites reinfusion, and etc.), or effusion obviously increased within 2 weeks after the local treatment and thus needs long-term catherterization. Candidates who meet any of the conditions above, or determined by the investigator as unsuitable, shall not be included.
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- 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 stem cell transplantation.
- 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 reproductive age (also including female spouse of reproductive age of male candidates), during the study or within 6 months after the last infusion, who will probably bear children, breastfeed, or are unwilling to cake effective contraceptives, as considered by the investigator.
- other conditions that are determined by the investigator as unsitable for entering this trial.
- For Expansion Cohort(Randomized, Double-blind, Placebo-controlled Part):
- The exclusion criteria are the same as those for the dose-escalation phase above, with the following additional or modified 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 progestins (megestrol acetate, medroxyprogesterone acetate), corticosteroids, anamorelin, cannabinoids, androgens, NSAIDs.
- 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 toxicity, serous effusion, cardiovascular disease, infections, etc.) apply identically as listed above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Wu DaWei, +86 10 8778 8495, wumingshi-117@163.com
Ning Li
About this study
The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.
Read the detailed description
This is a Phase I, open-label, dose-escalation study to investigate the safety, tolerability, pharmacokinetics and preliminary efficacy of SXRN Plasmid DNA Technique in patients with advanced solid tumors. Three dose levels are initially formulated, namely 2mg, 4mg, and 10mg of SXRN, adopting an accelerated titration followed by the traditional "3+3" design. SXRN will be administered daily x 5 with 2 days off (total of 21 days) for 3 weeks followed by a no-treatment observation period.
Add a continuous dosing exploration cohort: based on the Phase I dose-escalation study, a randomized, double-blind, placebo-controlled continuous dosing exploration cohort (utilizing an operationally seamless design) will be added to further evaluate the efficacy and safety of continuous administration of Shuxinrui Na Injection in patients with cancer anorexia-cachexia.
- Conditions
- Advanced Cancer, Cachexia
- Being tested
- SXRN, Placebo
- Keywords
- micoRNA
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SXRNDrug
SXRN is a naked plasmid DNA drug targeting miRNA.
PlaceboDrug
Matching placebo, same dosing regimen (IV infusion once daily for 14 days)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | In this study, three dose levels are initially formulated, namely 2mg, 4mg, and 10mg of SXRN, adopting an accelerated titration followed by the traditional "3+3" design. The first day of infusion for each dose is referred to as C1D1, with the administration of QD for 5 consecutive days, followed by a 2-day break; Each treatment cycle will last 3 weeks (21 days), and the subsequent infusion regimen, including interval, frequency and dose, may be adjusted based on the initial safety and PK parameters. Receives: Drug: SXRN |
| Expansion Cohort-Placebo | Placebo comparator | In the initial 2-week treatment period (Cycle 1), patients receive placebo, intravenous infusion, once daily for 14 consecutive days; in the subsequent 2 weeks (Cycle 2), all patients uniformly receive open-label treatment with 4 mg SXRN injection. Receives: Drug: Placebo |
| Expansion Cohort 1-SXRN 4mg | Experimental | In the initial 2-week treatment period (Cycle 1), patients receive 4 mg SXRN injection, intravenous infusion, once daily for 14 consecutive days; in the subsequent 2 weeks (Cycle 2), all patients uniformly receive open-label treatment with 4 mg SXRN injection. Receives: Drug: SXRN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN
To determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN in the treatment of advanced solid tumors
Measured: 12 months
Effect for SXRN on Appetite compared to placebo
measured by FAACT-A/CS-12 score; For the expansion cohort only.
Measured: Baseline, weekly up to Day 28
Effect of SXRN on physical function compared to placebo
measured by 6MWT; For the expansion cohort only
Measured: Baseline, Weekly up to Day 28
Secondary outcomes (9)
Pharmacokinetic parameters of SXRN
Maximum plasmid Concentration [Cmax]
Measured: 12 months
Preliminary anti-tumor efficacy of SXRN
Anti-tumor activity: objective remission rate (ORR), duration of remission (DOR), disease control rate (DCR), time to remission (TTR) and progression free survival (PFS) basing on RECIST v1.1; overall survival (OS);
Measured: 12 months
Weight improvement of SXRN in patients with advanced solid tumors
Body weight
Measured: 12 months
Appetite improvement of SXRN in patients with advanced solid tumors
Change in patient's quality of life on the FAACT-A/ CS-12 questionnaire (score)
Measured: 12 months
Pain alleviating efficacy of SXRN in patients with advanced solid tumors
Change in patient's quality of life on the numeric rate scale (NRS) questionnaire (score)
Measured: 12 months
Effect for SXRN on body weight/fat-free mass compared to placebo
For the expansion cohort only
Measured: Baseline, Weekly up to Day 28
Effect for SXRN on QoL compared to placebo
measured by EORTC QLQ-C30; For the expansion cohort only
Measured: Baseline, Weekly up to Day 28
Effect for SXRN on dietary intake compared to placebo
measured by Brief Dietary Self-Assessment Scale; For the expansion cohort only
Measured: Baseline, up to Day 28
Safety and tolerability of SXRN
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs),
Measured: Up to 28 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start2 Sep 2024
- Primary completion6 Oct 2027 (estimated)
- Study completion9 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Accelerated titration and "3+3" dose escalation: This study plans to start dose escalating from 2 mg, followed by 4 mg, and 10 mg as tentatively designated escalating dose groups. An "accelerated titration" strategy will be implemented in the early dose escalation phase (2 mg dose group) in this study, with only 1 subject enrolled. The newly added continuous dosing exploration cohort initially plans to include two study arms (a 4 mg dose group and a placebo control group). During the initial 2-week treatment period (Cycle 1), patients will be double-blindly randomized to receive either 4 mg or placebo, administered via intravenous infusion once daily for 14 consecutive days. In the subsequent 2 weeks (Cycle 2), all patients will uniformly receive open-label treatment with 4 mg.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nutai Biologics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Jiangsu GQ Pharma Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736275
- Sponsor's protocol ID
- AA0101
- Status last verified
- May 2026
- First submitted
- 1 Dec 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Garcia GE, Truong LD, Chen JF, Johnson RJ, Feng L. Adenosine A(2A) receptor activation prevents progressive kidney fibrosis in a model of immune-associated chronic inflammation. Kidney Int. 2011 Aug;80(4):378-88. doi: 10.1038/ki.2011.101. Epub 2011 Apr 20.
PubMed 21508927Wang Q, Liu Y, Wu Y, Wen J, Man C. Immune function of miR-214 and its application prospects as molecular marker. PeerJ. 2021 Feb 16;9:e10924. doi: 10.7717/peerj.10924. eCollection 2021.
PubMed 33628646Zhao L, Liu YW, Yang T, Gan L, Yang N, Dai SS, He F. The mutual regulation between miR-214 and A2AR signaling plays an important role in inflammatory response. Cell Signal. 2015 Oct;27(10):2026-34. doi: 10.1016/j.cellsig.2015.07.007. Epub 2015 Jul 11.
PubMed 26171727Takayama K, Atagi S, Imamura F, Tanaka H, Minato K, Harada T, Katakami N, Yokoyama T, Yoshimori K, Takiguchi Y, Hataji O, Takeda Y, Aoe K, Kim YH, Yokota S, Tabeta H, Tomii K, Ohashi Y, Eguchi K, Watanabe K. Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study. Support Care Cancer. 2016 Aug;24(8):3473-80. doi: 10.1007/s00520-016-3156-8. Epub 2016 Mar 22.
PubMed 27003901Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.
PubMed 16762946Malik M, Michalak M, Radecka B, Gelej M, Jackowska A, Filipczyk-Cisarz E, Hetman K, Foszczynska-Kloda M, Kania-Zembaczynska B, Manka D, Orlikowska M, Rogowska-Dros H, Bodnar L. Prognostic Value of Sarcopenia in Metastatic Colorectal Cancer Patients Treated with Trifluridine/Tipiracil. J Clin Med. 2021 Oct 30;10(21):5107. doi: 10.3390/jcm10215107.
PubMed 34768626Argiles JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014 Nov;14(11):754-62. doi: 10.1038/nrc3829. Epub 2014 Oct 9.
PubMed 25291291Loberg RD, Bradley DA, Tomlins SA, Chinnaiyan AM, Pienta KJ. The lethal phenotype of cancer: the molecular basis of death due to malignancy. CA Cancer J Clin. 2007 Jul-Aug;57(4):225-41. doi: 10.3322/canjclin.57.4.225.
PubMed 17626119Scarpi E, Maltoni M, Miceli R, Mariani L, Caraceni A, Amadori D, Nanni O. Survival prediction for terminally ill cancer patients: revision of the palliative prognostic score with incorporation of delirium. Oncologist. 2011;16(12):1793-9. doi: 10.1634/theoncologist.2011-0130. Epub 2011 Oct 31.
PubMed 22042788Mondello P, Mian M, Aloisi C, Fama F, Mondello S, Pitini V. Cancer cachexia syndrome: pathogenesis, diagnosis, and new therapeutic options. Nutr Cancer. 2015;67(1):12-26. doi: 10.1080/01635581.2015.976318. Epub 2014 Dec 16.
PubMed 25513730
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- AA0101
- Conditions
- Advanced Cancer, Cachexia
- Keywords
- micoRNA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Jiangsu Nutai Biologics Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Jiangsu GQ Pharma Co., Ltd.
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 9 Dec 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.
Detailed description
This is a Phase I, open-label, dose-escalation study to investigate the safety, tolerability, pharmacokinetics and preliminary efficacy of SXRN Plasmid DNA Technique in patients with advanced solid tumors. Three dose levels are initially formulated, namely 2mg, 4mg, and 10mg of SXRN, adopting an accelerated titration followed by the traditional "3+3" design. SXRN will be administered daily x 5 with 2 days off (total of 21 days) for 3 weeks followed by a no-treatment observation period.
Add a continuous dosing exploration cohort: based on the Phase I dose-escalation study, a randomized, double-blind, placebo-controlled continuous dosing exploration cohort (utilizing an operationally seamless design) will be added to further evaluate the efficacy and safety of continuous administration of Shuxinrui Na Injection in patients with cancer anorexia-cachexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Accelerated titration and "3+3" dose escalation: This study plans to start dose escalating from 2 mg, followed by 4 mg, and 10 mg as tentatively designated escalating dose groups. An "accelerated titration" strategy will be implemented in the early dose escalation phase (2 mg dose group) in this study, with only 1 subject enrolled. The newly added continuous dosing exploration cohort initially plans to include two study arms (a 4 mg dose group and a placebo control group). During the initial 2-week treatment period (Cycle 1), patients will be double-blindly randomized to receive either 4 mg or placebo, administered via intravenous infusion once daily for 14 consecutive days. In the subsequent 2 weeks (Cycle 2), all patients will uniformly receive open-label treatment with 4 mg.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: SXRNIn this study, three dose levels are initially formulated, namely 2mg, 4mg, and 10mg of SXRN, adopting an accelerated titration followed by the traditional "3+3" design. The first day of infusion for each dose is referred to as C1D1, with the administration of QD for 5 consecutive days, followed by a 2-day break; Each treatment cycle will last 3 weeks (21 days), and the subsequent infusion regimen, including interval, frequency and dose, may be adjusted based on the initial safety and PK parameters. |
| Expansion Cohort-Placebo | Placebo comparator | Drug: PlaceboIn the initial 2-week treatment period (Cycle 1), patients receive placebo, intravenous infusion, once daily for 14 consecutive days; in the subsequent 2 weeks (Cycle 2), all patients uniformly receive open-label treatment with 4 mg SXRN injection. |
| Expansion Cohort 1-SXRN 4mg | Experimental | Drug: SXRNIn the initial 2-week treatment period (Cycle 1), patients receive 4 mg SXRN injection, intravenous infusion, once daily for 14 consecutive days; in the subsequent 2 weeks (Cycle 2), all patients uniformly receive open-label treatment with 4 mg SXRN injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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;
Key exclusion criteria (32 listed)
- Subjects 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 initial infusion.b)received an oral small-molecule targeted anti-tumor agent within 2 weeks before the first infusion or for five half-lives(whichever was shorter).c) received anti-tumor Chinese patent medicine approved by NMPA within 2 weeks before the initial infusion.d) received more than 30% bone marrow radiotherapy or large area radiotherapy within 2 weeks before initial infusion (palliative radiotherapy at the bone or superficial lesions is acceptable).
- 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 interventional 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, asymptomatic hypothyroidism caused by immune checkpoint inhibitors that can be treated with only thyroid hormone and remains stable, and etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SXRNSXRN is a naked plasmid DNA drug targeting miRNA. | Drug | Dose Escalation, Expansion Cohort 1-SXRN 4mg |
| PlaceboMatching placebo, same dosing regimen (IV infusion once daily for 14 days) | Drug | Expansion Cohort-Placebo |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN
Time frame: 12 months
To determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN in the treatment of advanced solid tumors
Effect for SXRN on Appetite compared to placebo
Time frame: Baseline, weekly up to Day 28
measured by FAACT-A/CS-12 score; For the expansion cohort only.
Effect of SXRN on physical function compared to placebo
Time frame: Baseline, Weekly up to Day 28
measured by 6MWT; For the expansion cohort only
9 secondary outcomes
Pharmacokinetic parameters of SXRN
Time frame: 12 months
Preliminary anti-tumor efficacy of SXRN
Time frame: 12 months
Weight improvement of SXRN in patients with advanced solid tumors
Time frame: 12 months
Appetite improvement of SXRN in patients with advanced solid tumors
Time frame: 12 months
Pain alleviating efficacy of SXRN in patients with advanced solid tumors
Time frame: 12 months
Effect for SXRN on body weight/fat-free mass compared to placebo
Time frame: Baseline, Weekly up to Day 28
Effect for SXRN on QoL compared to placebo
Time frame: Baseline, Weekly up to Day 28
Effect for SXRN on dietary intake compared to placebo
Time frame: Baseline, up to Day 28
Safety and tolerability of SXRN
Time frame: Up to 28 days after first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 21508927Garcia GE, Truong LD, Chen JF, Johnson RJ, Feng L. Adenosine A(2A) receptor activation prevents progressive kidney fibrosis in a model of immune-associated chronic inflammation. Kidney Int. 2011 Aug;80(4):378-88. doi: 10.1038/ki.2011.101. Epub 2011 Apr 20.
- Background: PubMed 33628646Wang Q, Liu Y, Wu Y, Wen J, Man C. Immune function of miR-214 and its application prospects as molecular marker. PeerJ. 2021 Feb 16;9:e10924. doi: 10.7717/peerj.10924. eCollection 2021.
- Background: PubMed 26171727Zhao L, Liu YW, Yang T, Gan L, Yang N, Dai SS, He F. The mutual regulation between miR-214 and A2AR signaling plays an important role in inflammatory response. Cell Signal. 2015 Oct;27(10):2026-34. doi: 10.1016/j.cellsig.2015.07.007. Epub 2015 Jul 11.
- Background: PubMed 27003901Takayama K, Atagi S, Imamura F, Tanaka H, Minato K, Harada T, Katakami N, Yokoyama T, Yoshimori K, Takiguchi Y, Hataji O, Takeda Y, Aoe K, Kim YH, Yokota S, Tabeta H, Tomii K, Ohashi Y, Eguchi K, Watanabe K. Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study. Support Care Cancer. 2016 Aug;24(8):3473-80. doi: 10.1007/s00520-016-3156-8. Epub 2016 Mar 22.
- Background: PubMed 16762946Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.
- Background: PubMed 34768626Malik M, Michalak M, Radecka B, Gelej M, Jackowska A, Filipczyk-Cisarz E, Hetman K, Foszczynska-Kloda M, Kania-Zembaczynska B, Manka D, Orlikowska M, Rogowska-Dros H, Bodnar L. Prognostic Value of Sarcopenia in Metastatic Colorectal Cancer Patients Treated with Trifluridine/Tipiracil. J Clin Med. 2021 Oct 30;10(21):5107. doi: 10.3390/jcm10215107.
- Background: PubMed 25291291Argiles JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014 Nov;14(11):754-62. doi: 10.1038/nrc3829. Epub 2014 Oct 9.
- Background: PubMed 17626119Loberg RD, Bradley DA, Tomlins SA, Chinnaiyan AM, Pienta KJ. The lethal phenotype of cancer: the molecular basis of death due to malignancy. CA Cancer J Clin. 2007 Jul-Aug;57(4):225-41. doi: 10.3322/canjclin.57.4.225.
- Background: PubMed 22042788Scarpi E, Maltoni M, Miceli R, Mariani L, Caraceni A, Amadori D, Nanni O. Survival prediction for terminally ill cancer patients: revision of the palliative prognostic score with incorporation of delirium. Oncologist. 2011;16(12):1793-9. doi: 10.1634/theoncologist.2011-0130. Epub 2011 Oct 31.
- Background: PubMed 25513730Mondello P, Mian M, Aloisi C, Fama F, Mondello S, Pitini V. Cancer cachexia syndrome: pathogenesis, diagnosis, and new therapeutic options. Nutr Cancer. 2015;67(1):12-26. doi: 10.1080/01635581.2015.976318. Epub 2014 Dec 16.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SXRN in people with Advanced Cancer and Cachexia, run by Jiangsu Nutai Biologics Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li (+86 10 8778 8713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736275, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.