Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT07100210

A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity

Led by Xingchen Peng · Updated on 2025-12-29

6

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to investigate the safety and efficacy of the IL-22BP/LNP compound in patients with refractory malignant solid tumors, such as advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, and malignant melanoma, who have failed second-line treatment, have advanced recurrence or metastatic malignant solid tumors.

CONDITIONS

Official Title

A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 to 70 years old
  • Histopathologically confirmed refractory advanced recurrent or metastatic malignant solid tumors, including advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, and malignant melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Expected survival time of at least 3 months
  • At least 28 days since last chemotherapy, radiotherapy, or surgery
  • At least 6 weeks since last use of nitrosoureas or mitomycin C
  • Main organ functions are in good condition
  • Signed written informed consent form
Not Eligible

You will not qualify if you...

  • Participation in other drug clinical trials within 4 weeks
  • Tumor located near major blood vessels or the trachea
  • Uncontrolled cardiac symptoms or diseases, including heart failure NYHA class II or above, unstable angina, recent myocardial infarction within 1 year, or significant arrhythmias requiring treatment
  • Pregnant or lactating women
  • Active tuberculosis, bacterial or fungal infections grade 2 or higher, active HIV, HBV, or HCV infection
  • History of psychotropic drug abuse or mental disorders
  • Active autoimmune diseases or history of autoimmune diseases, except vitiligo or childhood asthma fully resolved without intervention
  • Current immunosuppressive treatment
  • History of drug abuse or known medical, psychological, or social conditions such as alcoholism
  • Known allergy or intolerance to IL-22BP/LNP or any excipients, or severe allergy history to drugs, foods, or vaccines
  • Pregnancy plans for female subjects or male partners within 12 months after drug injection
  • Other serious diseases that endanger safety or study completion as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

X

Xingchen Peng

CONTACT

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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