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

NCT07231120 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

DRUG

SXRN Injection

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

Sponsors & Collaborators

  • Jiangsu GQ Pharma Co., Ltd.

    collaborator UNKNOWN

  • Jiangsu Nutai Biologics Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-11-09
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07231120 on ClinicalTrials.gov