Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05392699

ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2022-06-22

60

Participants Needed

1

Research Sites

240 weeks

Total Duration

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AI-Summary

What this Trial Is About

Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection. The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.

CONDITIONS

Official Title

ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years and older
  • Able to understand and voluntarily sign informed consent
  • Histopathologically confirmed recurrent or metastatic solid tumors
  • Prior standard systemic therapy failed, was not tolerated, or no standard therapy exists
  • At least one measurable lesion according to RECIST Version 1.1
  • At least one superficial or deep lesion suitable for intratumoral injection and biopsy
  • Adequate organ function
  • ECOG performance status of 0 or 1
  • Weight greater than 30 kg
  • Expected survival longer than 12 weeks
  • Female patients must be postmenopausal or have a negative pregnancy test if of childbearing potential
Not Eligible

You will not qualify if you...

  • Received systemic anti-tumor therapy within 28 days before first dose
  • Radiotherapy within 14 days before first dose
  • Use of immunosuppressants
  • Major surgery within 28 days before first dose
  • Poorly controlled or unstable diseases
  • Active autoimmune or inflammatory diseases
  • Symptomatic central nervous system tumors or metastases
  • Persistent toxicity from prior anti-tumor therapy at grade 2 or higher
  • Other cancers within past 5 years except certain cured in situ or superficial cancers
  • Active infections
  • Any condition increasing risk or affecting study compliance 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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Actively Recruiting

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Research Team

D

Dawei Wu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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