A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia

NCT07231120 | Recruiting Phase 1

• 1 other identifier: AA0102
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cachexia-Anorexia Syndrome; Solid Tumor Malignancies

Keywords

cancer patient with anorexia-cachexia

Outcome Measures

Primary Outcomes (3)

• Phase Ia: MTD

  To determine the Maximum Tolerated Dose (MTD) of SXRN Injection for the treatment of caner anorexia-cachexia.

  Up to 90 days post last dosing

• Phase Ia&Ib: Incidence of Dose Limiting Toxicities (DLTs)

  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.

  Up to 90 days post last dosing

Secondary Outcomes (12)

• Maximum serum concentration (Cmax) of SXRN Injection;

  Up to 90 days after the last dosing of SXRN Injection

• Time to Cmax (Tmax) of SXRN Injection

  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

  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.

  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.

  Within 24 weeks from baseline

Study Arms (1)

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.

Drug: SXRN Injection

Interventions

SXRN Injection DRUG

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

SXRN

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF);
• \. 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;
• \. 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);
• ③ CRP \>5 mg/L;
• \. (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;
• \. (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;
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
• \. Life expectancy ≥12 weeks.
• \. 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).

You may not qualify if:

• Participants meeting any of the following criteria shall be excluded from the study:
• \. 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;
• \. 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;
• \. Patients currently receiving tube feeding or parenteral nutrition support;
• \. 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;
• \. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;
• \. Hormonal therapy judged by the investigator as potentially to improve the assessment of cachexia-related outcomes.
• \. 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.);
• \. 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);
• \. 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;
• Patients with central nervous system metastases requiring intervention;
• 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.);
• History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
• (Non-infectious) pulmonary inflammation/interstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;
• History of severe cardiovascular or cerebrovascular diseases, including but not limited to:

Sponsors & Collaborators

• Jiangsu Nutai Biologics Co., Ltd: lead
• Jiangsu GQ Pharma Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (15)

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  PMID: 27637832 BACKGROUND

Central Study Contacts

Ning Li

CONTACT

+86 1087788713; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 17, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)