Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
ID07231120

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

Led by Jiangsu Nutai Biologics Co., Ltd · Updated on 2025-12-08

54

Participants Needed

1

Research Sites

7 weeks

Total Duration

On this page

Sponsors

J

Jiangsu Nutai Biologics Co., Ltd

Lead Sponsor

J

Jiangsu GQ Pharma Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, and early effects of SXRN Injection in cancer patients suffering from anorexia-cachexia. This clinical trial has two phases: Phase Ia is a single-arm, open-label study with dose escalation, and Phase Ib extends the study by combining SXRN Injection with standard anti-tumor therapies in cancers like pancreatic cancer, non-small cell lung cancer, and colon cancer. The study is sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd. In Phase Ia, participants receive one of 3 to 4 escalating doses of SXRN Injection (4 mg, 6 mg, 8 mg, or another dose), given intravenously once daily for 5 days followed by a 2-day break, forming a 3-week treatment cycle. Phase Ib includes two dose levels (6 mg and 8 mg) combined with standard anti-tumor treatment. Participants are enrolled sequentially by dose levels. The study plans to enroll 12-24 patients in Phase Ia and 20-30 in Phase Ib and is conducted at 1-2 centers nationwide. Participants will undergo various assessments including blood tests, physical function tests, weight and body composition measurements, questionnaires on appetite and quality of life, and tumor evaluations. Researchers will monitor side effects, drug levels in the body, and treatment responses up to 12 months or longer. The primary outcomes include maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose. Secondary measures involve changes in appetite, physical function, body weight, survival, and tumor response. Participants will be followed closely during and after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 75 years at consent
  • Histologically or cytologically confirmed advanced solid tumors with measurable or evaluable lesions
  • Diagnosed with cancer anorexia-cachexia meeting specific weight loss and appetite loss criteria
  • (Phase Ia) Failed or intolerant to prior standard therapy or lacking effective options
  • (Phase Ib) Needing standard anti-tumor therapy for pancreatic, non-small cell lung, colorectal, or other eligible cancers
  • ECOG performance status of 0 to 2
  • Life expectancy of at least 12 weeks
  • Lab tests showing adequate blood counts, liver and kidney function, urine protein, coagulation, and heart function within specified ranges
  • Able to understand and voluntarily sign informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Reversible causes of reduced food intake like mechanical obstruction
  • Use of appetite-improving medications within 28 days prior to study drug
  • Receiving tube feeding or parenteral nutrition
  • Treatment with other investigational drugs within 4 weeks prior
  • Cachexia due to other diseases like severe COPD or AIDS
  • Hormonal therapy affecting cachexia assessments
  • Major surgery within 4 weeks prior or planned during trial (excluding biopsy)
  • Unrecovered toxicities from prior antitumor therapies above specified grades
  • Uncontrolled fluid accumulations like pleural effusion or ascites
  • CNS metastases needing intervention
  • History of other malignancies unless cured with no recurrence for 5 years
  • Immunodeficiency or bone marrow transplantation history
  • Recent pulmonary inflammation requiring steroids
  • Severe cardiovascular or cerebrovascular diseases
  • Uncontrolled hypertension
  • Active hepatitis B, hepatitis C, or HIV infection
  • Active infections requiring treatment within 2 weeks prior
  • Active tuberculosis within 1 year prior
  • Other uncontrolled significant comorbidities
  • Allergy or contraindication to SXRN Injection or related substances
  • For premenopausal females: positive pregnancy test, breastfeeding, or unwilling to use contraception
  • Any condition judged unsuitable by investigator for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 3-week cycles until disease progression or discontinuation

Participants receive SXRN Injection through intravenous infusion once daily for 5 consecutive days, followed by a 2-day break; this cycle repeats every 3 weeks. Phase Ia involves dose escalation with 3 to 4 dose cohorts, while Phase Ib combines SXRN Injection with standard anti-tumor therapy for specific cancers.

Treatment cycles every 3 weeks with daily infusions for 5 days and breaks

Follow-up

Duration - Up to 12 months after treatment

Participants are monitored for safety, tolerability, pharmacokinetics, and preliminary efficacy outcomes for up to 90 days after the last dose, with additional assessments up to 12 months for overall survival and progression-free survival.

Periodic visits for assessments up to 12 months

Trial Site Locations

Total: 1 location

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

N

Ning Li

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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