Cachexia-Anorexia SyndromePhase 1NCT07231120
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia
A Phase 1 study testing SXRN Injection in people with Cachexia-Anorexia Syndrome and Solid Tumor Malignancies, run by Jiangsu Nutai Biologics Co., Ltd at 1 site in China.
Trial summary
This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cachexia-Anorexia Syndrome, Solid Tumor Malignancies
- What is being tested?
- SXRN Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2025to 30 Dec 2026
- Phase
- 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
- Participants must meet all the following criteria for inclusion:
- 1. Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF);
- 2. Patients with histologically or cytologically confirmed advanced solid tumors, with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- 3. Diagnosed of cancer anorexia-cachexia based on the 2025 Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome and referring to Chinese population characteristics, i.e., meeting the following criteria (either ① + ② or ① + ③):
- ① >5% involuntary weight loss within the past 6 months; or >2% weight loss if BMI <18.5 kg/m²; or >2% weight loss in the presence of reduced muscle mass;
- ② Anorexia (VAS score ≤70, or FAACT-A/CS score ≤37);
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- ③ CRP >5 mg/L;
- 4. (Phase Ia only) Cancer patients who have failed or are intolerant (experienced drug-related ≥ Grade 4 hematologic toxicity, or ≥ Grade 3 non-hematologic toxicity) to prior standard therapy, or lack effective conventional treatment options;
- 5. (Phase Ib only) Patients requiring standard anti-tumor drug therapy per CSCO guidelines of advanced pancreatic cancer, non-small cell lung cancer, colorectal cancer, or other eligible solid tumors;
- 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- 7. Life expectancy ≥12 weeks.
- 8. Laboratory test results and organ function assessed within 7 days prior to the first dose must meet the following criteria:
- Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10^9/L;2)Platlets (PLT) Count≥75×10^9/L; 3)Hemoglobins (Hb) ≥80 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 ≥30 mL/min; 3)Aspartate Amino Transferase (AST), Alanine Aminotransferase (ALT) ≤3×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g/L.
- Urine routines: Urine protein ≤2+ (if >2+, 24-hour urine protein quantification must be performed, and total protein ≤1 g is required for eligibility).
- Blood coagulation: 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.
- Ultrasonic cardiogram: Left Ventricular Ejection Fraction (LVEF) ≥50%.
- 9.The participant must be able to understand and voluntarily sign the written Informed Consent Form (ICF); and must be willing and able to comply with all study procedures and follow-up examinations.
Who cannot join
- Participants meeting any of the following criteria shall be excluded from the study:
- 1. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction preventing adequate oral intake;
- 2. Use of any prescription medication intended to improve appetite or mitigate weight loss within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the investigational product, including but not limited to anamorelin, megestrol acetate, cannabinoids, or medical marijuana;
- 3. Patients currently receiving tube feeding or parenteral nutrition support;
- 4. Treatment with any other investigational drug within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the study drug;
- 5. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;
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- 6. Hormonal therapy judged by the investigator as potentially to improve the assessment of cachexia-related outcomes.
- 7. Patients who have undergone major surgery or interventional procedures within 4 weeks prior to the first dose, or who are scheduled to undergo such procedures during the trial (excluding tumor biopsy, puncture, etc.);
- 8. Patients with toxicities from previous antitumor therapies that have not yet recovered to ≤ Grade 1 or baseline levels (except for toxicities judged by the investigator as to pose no safety risk, such as alopecia, or asymptomatic hypothyroidism induced by immune checkpoint inhibitors that is stable and only requires thyroid hormone replacement therapy);
- 9. Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion), meeting any of the following criteria: moderate or larger volume, received local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy, etc.) within 2 weeks before screening or scheduled within the next 2 weeks, significant re-accumulation within 2 weeks after local treatment, or requiring long-term catheterization; or judged by the investigator as unsuitable for enrollment;
- 10.Patients with central nervous system metastases requiring intervention;
- 11.History of other malignancies, except for those who have undergone curative treatment with no recurrence within 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, etc.);
- 12.History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
- 13.(Non-infectious) pulmonary inflammation/interstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;
- 14.History of severe cardiovascular or cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;
- Cardiac dysfunction classified as Class III-IV per the New York Heart Association (NYHA) criteria;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular/cerebrovascular events within 6 months prior to the first dose;
- 15.Hypertension uncontrolled by a stable regimen of antihypertensive medication (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg);
- 16.Active chronic hepatitis B (e.g., HBsAg positive or HBcAb positive with HBV DNA above the lower limit of detection), active hepatitis C (e.g., HCV antibody positive with HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection;
- 17.Active infection requiring systemic therapy within 2 weeks prior to the first dose;
- 18.History of active tuberculosis infection within 1 year prior to the first dose;
- 19.Any other uncontrolled or significant comorbid disease(s), either currently or historically, that by the investigator's judgment may interfere with trial participation or evaluation;
- 20.Known allergy or contraindication to the investigational product (SXRN injection) or its drug substance process-related impurities (e.g., spectinomycin);
- 21.For premenopausal female participants (postmenopausal females must be amenorrheic for at least 12 months to be considered of non-childbearing potential): serum pregnancy test as positive, or participants of childbearing potential (including female partners of male participants) who, in the investigator's opinion, are likely to become pregnant, are breastfeeding, or are unwilling to use effective contraception during the study and for at least 6 months after the last dose of the investigational product;
- 22. Any other condition that considered by the investigator as to render the patient unsuitable for participation in the study.
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, Beijing Municipality
About this study
This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Phase Ib, an extension of the study, utilizes a design of combination therapy with standard anti-tumor therapy for cancers including but not limited to pancreatic cancer, non-small cell lung cancer (NSCLC), and colon cancer.
Read the detailed description
This study is collaboratively sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd.. Nutai serves as the Responsible Party for this registration.
- Being tested
- SXRN Injection
- Keywords
- cancer patient with anorexia-cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SXRN InjectionDrug
Intravenous infusion, qd for 5 consecutive days, followed by a 2-day break; every 3 weeks (21days) makes a treatment cycle. Ⅰa phase：conventional "3+3" design for dose escalation； Ⅰb phase：standard anti-tumor therapy combined with SXRN Injection
| Study group | Role | What they receive |
|---|---|---|
| SXRN | Experimental | Phase Ia: 3~4 dose cohorts are initially formulated, namely: 4 mg, 6mg, 8mg, and Xmg of SXRN Injection, utilizing the conventional "3+3" design for dose escalation. Participants will be enrolled sequentially into the 3~4 dose cohorts, starting from low to high.
Phase Ib: 2 dose cohorts of SXRN Injection (tentatively 6 mg and 8 mg, based on phase Ia data) are initially formulated, in patients with cancers including but not limited to pancreatic cancer, non-small cell lung cancer, and colon cancer. Treatment will combine the standard anti-tumor therapy with SXRN Injection.
The infusion on the first day for each dose cohort is referred to as C1D1, with the administration qd for 5 consecutive days, followed by a 2-day break; Each treatment cycle spans 3 weeks (21 days).
The study plans to enroll 12-24 participants for phase Ia and 20-30 participants for phase Ib, and will be conducted at 1-2 center(s) nationwide. Receives: Drug: SXRN Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: MTD
To determine the Maximum Tolerated Dose (MTD) of SXRN Injection for the treatment of caner anorexia-cachexia.
Measured: Up to 90 days post last dosing
Phase Ia&Ib: Incidence of Dose Limiting Toxicities (DLTs)
Measured: Up to 21 days after the first dosing of SXRN Injection for each patient
Phase Ib: RP2D
To determine the Recommended Phase II Dose (RP2D) of SXRN Injection.
Measured: Up to 90 days post last dosing
Secondary outcomes (12)
Maximum serum concentration (Cmax) of SXRN Injection;
Measured: Up to 90 days after the last dosing of SXRN Injection
Time to Cmax (Tmax) of SXRN Injection
Measured: Up to 90 days after the last dosing of SXRN Injection
Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of SXRN Injection
Measured: Up to 90 days after the last dosing of SXRN Injection
Phase Ia&Ib: Average change in the severity of anorexia (based on the Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale-12 [FAACT-A/CS-12]) in the first cycle from baseline to each assessment timepoint.
Measured: Within 24 weeks from baseline
Phase Ia&Ib: Average change in quality of life (based on the EORTC Quality of Life Questionnaire [QLQ-C30]) in the first cycle from baseline to each assessment timepoint.
Measured: Within 24 weeks from baseline
Phase Ia&Ib: Average changes in comprehensive physical function (based on the 6-minute walk test [6MWT]) from baseline to each assessment timepoint.
Measured: Within 24 weeks from baseline
Phase Ia&Ib: Average change in body weight/lean body mass(LBM) from baseline to each assessment timepoint
Measured: Within 24 weeks from baseline
Overall sunvival (OS)
Measured: 12 months
progression free survival(PFS)
Measured: 12 months
Objective response rate(ORR)
Measured: baseline, week 6, weeks 12,week 18, week 24
Disease control rate(DCR)
Measured: baseline, week 6, weeks 12,week 18, week 24
Phase Ia&Ib: Average change in pain assessed using analgesic medication records per cycle from baseline to each assessment timepoint.
Use the analgesic medication record form to document the type, dosage, and frequency of analgesics taken by the subject, thereby evaluating changes in the subject's pain level.
Measured: Within 24 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start17 Nov 2025
- Primary completion9 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cachexia-Anorexia SyndromeStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nutai Biologics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu GQ Pharma Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231120
- Sponsor's protocol ID
- AA0102
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagnon B, Murphy J, Simonyan D, Penafuerte CA, Sirois J, Chasen M, Tremblay ML. Cancer anorexia-cachexia syndrome is characterized by more than one inflammatory pathway. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1041-1053. doi: 10.1002/jcsm.13430. Epub 2024 Mar 13.
PubMed 38481033Clamon G, Byrne MM, Talbert EE. Inflammation as a Therapeutic Target in Cancer Cachexia. Cancers (Basel). 2022 Oct 26;14(21):5262. doi: 10.3390/cancers14215262.
PubMed 36358681Garcia 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 21508927Day YJ, Marshall MA, Huang L, McDuffie MJ, Okusa MD, Linden J. Protection from ischemic liver injury by activation of A2A adenosine receptors during reperfusion: inhibition of chemokine induction. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G285-93. doi: 10.1152/ajpgi.00348.2003.
PubMed 14715520Zhang H, Garcia JM. Anamorelin hydrochloride for the treatment of cancer-anorexia-cachexia in NSCLC. Expert Opin Pharmacother. 2015 Jun;16(8):1245-53. doi: 10.1517/14656566.2015.1041500. Epub 2015 May 6.
PubMed 25945893Mochamat, Cuhls H, Marinova M, Kaasa S, Stieber C, Conrad R, Radbruch L, Mucke M. A systematic review on the role of vitamins, minerals, proteins, and other supplements for the treatment of cachexia in cancer: a European Palliative Care Research Centre cachexia project. J Cachexia Sarcopenia Muscle. 2017 Feb;8(1):25-39. doi: 10.1002/jcsm.12127. Epub 2016 Jul 20.
PubMed 27897391Anderson LJ, Albrecht ED, Garcia JM. Erratum to: Update on Management of Cancer-Related Cachexia. Curr Oncol Rep. 2017 Mar;19(3):22. doi: 10.1007/s11912-017-0595-4. No abstract available.
PubMed 28293870Dev R, Wong A, Hui D, Bruera E. The Evolving Approach to Management of Cancer Cachexia. Oncology (Williston Park). 2017 Jan 15;31(1):23-32.
PubMed 28090619Kimura M, Naito T, Kenmotsu H, Taira T, Wakuda K, Oyakawa T, Hisamatsu Y, Tokito T, Imai H, Akamatsu H, Ono A, Kaira K, Murakami H, Endo M, Mori K, Takahashi T, Yamamoto N. Prognostic impact of cancer cachexia in patients with advanced non-small cell lung cancer. Support Care Cancer. 2015 Jun;23(6):1699-708. doi: 10.1007/s00520-014-2534-3. Epub 2014 Nov 29.
PubMed 25430482Takayama 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 27003901Jain R, Handorf E, Khare V, Blau M, Chertock Y, Hall MJ. Impact of Baseline Nutrition and Exercise Status on Toxicity and Outcomes in Phase I and II Oncology Clinical Trial Participants. Oncologist. 2020 Feb;25(2):161-169. doi: 10.1634/theoncologist.2019-0289. Epub 2019 Nov 20.
PubMed 32043776Baracos VE, Martin L, Korc M, Guttridge DC, Fearon KCH. Cancer-associated cachexia. Nat Rev Dis Primers. 2018 Jan 18;4:17105. doi: 10.1038/nrdp.2017.105.
PubMed 29345251Scherbakov N, Doehner W. Cachexia as a common characteristic in multiple chronic disease. J Cachexia Sarcopenia Muscle. 2018 Dec;9(7):1189-1191. doi: 10.1002/jcsm.12388. Epub 2019 Jan 13. No abstract available.
PubMed 30637985Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PubMed 21296615Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
PubMed 27637832
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia
- ClinicalTrials.gov ID
- NCT07231120
- Acronym / sponsor ID
- AA0102
- Keywords
- cancer patient with anorexia-cachexia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jiangsu Nutai Biologics Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Jiangsu GQ Pharma Co., Ltd.
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 9 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Nov 2025 (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.
This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Phase Ib, an extension of the study, utilizes a design of combination therapy with standard anti-tumor therapy for cancers including but not limited to pancreatic cancer, non-small cell lung cancer (NSCLC), and colon cancer.
Detailed description
This study is collaboratively sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd.. Nutai serves as the Responsible Party for this registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SXRN | Experimental | Drug: SXRN InjectionPhase Ia: 3~4 dose cohorts are initially formulated, namely: 4 mg, 6mg, 8mg, and Xmg of SXRN Injection, utilizing the conventional "3+3" design for dose escalation. Participants will be enrolled sequentially into the 3~4 dose cohorts, starting from low to high. Phase Ib: 2 dose cohorts of SXRN Injection (tentatively 6 mg and 8 mg, based on phase Ia data) are initially formulated, in patients with cancers including but not limited to pancreatic cancer, non-small cell lung cancer, and colon cancer. Treatment will combine the standard anti-tumor therapy with SXRN Injection. The infusion on the first day for each dose cohort is referred to as C1D1, with the administration qd for 5 consecutive days, followed by a 2-day break; Each treatment cycle spans 3 weeks (21 days). The study plans to enroll 12-24 participants for phase Ia and 20-30 participants for phase Ib, and will be conducted at 1-2 center(s) nationwide. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 1. Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF);
- 2. Patients with histologically or cytologically confirmed advanced solid tumors, with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- 3. Diagnosed of cancer anorexia-cachexia based on the 2025 Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome and referring to Chinese population characteristics, i.e., meeting the following criteria (either ① + ② or ① + ③):
- ① >5% involuntary weight loss within the past 6 months; or >2% weight loss if BMI <18.5 kg/m²; or >2% weight loss in the presence of reduced muscle mass;
- ② Anorexia (VAS score ≤70, or FAACT-A/CS score ≤37);
Key exclusion criteria (26 listed)
- 1. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction preventing adequate oral intake;
- 2. Use of any prescription medication intended to improve appetite or mitigate weight loss within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the investigational product, including but not limited to anamorelin, megestrol acetate, cannabinoids, or medical marijuana;
- 3. Patients currently receiving tube feeding or parenteral nutrition support;
- 4. Treatment with any other investigational drug within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the study drug;
- 5. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, 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 |
|---|---|---|
| SXRN InjectionIntravenous infusion, qd for 5 consecutive days, followed by a 2-day break; every 3 weeks (21days) makes a treatment cycle. Ⅰa phase：conventional "3+3" design for dose escalation； Ⅰb phase：standard anti-tumor therapy combined with SXRN Injection | Drug | SXRN |
Primary outcome
Phase Ia: MTD
Time frame: Up to 90 days post last dosing
To determine the Maximum Tolerated Dose (MTD) of SXRN Injection for the treatment of caner anorexia-cachexia.
Phase Ia&Ib: Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Up to 21 days after the first dosing of SXRN Injection for each patient
Phase Ib: RP2D
Time frame: Up to 90 days post last dosing
To determine the Recommended Phase II Dose (RP2D) of SXRN Injection.
12 secondary outcomes
Maximum serum concentration (Cmax) of SXRN Injection;
Time frame: Up to 90 days after the last dosing of SXRN Injection
Time to Cmax (Tmax) of SXRN Injection
Time frame: Up to 90 days after the last dosing of SXRN Injection
Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of SXRN Injection
Time frame: Up to 90 days after the last dosing of SXRN Injection
Phase Ia&Ib: Average change in the severity of anorexia (based on the Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale-12 [FAACT-A/CS-12]) in the first cycle from baseline to each assessment timepoint.
Time frame: Within 24 weeks from baseline
Phase Ia&Ib: Average change in quality of life (based on the EORTC Quality of Life Questionnaire [QLQ-C30]) in the first cycle from baseline to each assessment timepoint.
Time frame: Within 24 weeks from baseline
Phase Ia&Ib: Average changes in comprehensive physical function (based on the 6-minute walk test [6MWT]) from baseline to each assessment timepoint.
Time frame: Within 24 weeks from baseline
Phase Ia&Ib: Average change in body weight/lean body mass(LBM) from baseline to each assessment timepoint
Time frame: Within 24 weeks from baseline
Overall sunvival (OS)
Time frame: 12 months
progression free survival(PFS)
Time frame: 12 months
Objective response rate(ORR)
Time frame: baseline, week 6, weeks 12,week 18, week 24
Disease control rate(DCR)
Time frame: baseline, week 6, weeks 12,week 18, week 24
Phase Ia&Ib: Average change in pain assessed using analgesic medication records per cycle from baseline to each assessment timepoint.
Time frame: Within 24 weeks from baseline
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 8 Dec 2025.
- Background: PubMed 38481033Gagnon B, Murphy J, Simonyan D, Penafuerte CA, Sirois J, Chasen M, Tremblay ML. Cancer anorexia-cachexia syndrome is characterized by more than one inflammatory pathway. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1041-1053. doi: 10.1002/jcsm.13430. Epub 2024 Mar 13.
- Background: PubMed 36358681Clamon G, Byrne MM, Talbert EE. Inflammation as a Therapeutic Target in Cancer Cachexia. Cancers (Basel). 2022 Oct 26;14(21):5262. doi: 10.3390/cancers14215262.
- 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 14715520Day YJ, Marshall MA, Huang L, McDuffie MJ, Okusa MD, Linden J. Protection from ischemic liver injury by activation of A2A adenosine receptors during reperfusion: inhibition of chemokine induction. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G285-93. doi: 10.1152/ajpgi.00348.2003.
- Background: PubMed 25945893Zhang H, Garcia JM. Anamorelin hydrochloride for the treatment of cancer-anorexia-cachexia in NSCLC. Expert Opin Pharmacother. 2015 Jun;16(8):1245-53. doi: 10.1517/14656566.2015.1041500. Epub 2015 May 6.
- Background: PubMed 27897391Mochamat, Cuhls H, Marinova M, Kaasa S, Stieber C, Conrad R, Radbruch L, Mucke M. A systematic review on the role of vitamins, minerals, proteins, and other supplements for the treatment of cachexia in cancer: a European Palliative Care Research Centre cachexia project. J Cachexia Sarcopenia Muscle. 2017 Feb;8(1):25-39. doi: 10.1002/jcsm.12127. Epub 2016 Jul 20.
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- Individual participant dataSharing planned: No
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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 Phase 1 study testing SXRN Injection in people with Cachexia-Anorexia Syndrome and Solid Tumor Malignancies, 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 20 inclusion and 26 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 8 Dec 2025. 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. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 1087788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: MTD (time frame: Up to 90 days post last dosing). 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 NCT07231120, which also lists 15 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 8 Dec 2025.