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Recruiting NCT05392699

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

Phase I Interventional Patients With Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: human single chain IL-12 mRNA-single dose, human single chain IL-12 mRNA-multiple dose.
Who it may be relevant to
Registry conditions: Patients With Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-blind Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

Overview

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.

Interventions

  • Biological human single chain IL-12 mRNA-single dose
    human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only
  • Biological human single chain IL-12 mRNA-multiple dose
    human single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks

Primary outcome measures

  • Number of Participants Experiencing dose-limiting toxicities (DLTs) [Time frame: From first dose to Day 28]
  • Number of Participants Experiencing Adverse Events (AEs) [Time frame: From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months]
  • Number of Participants Experiencing Severe Adverse Events (SAEs) [Time frame: From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months]
Secondary outcome measures (10)
  • Overall Response Rate (ORR) [Time frame: Up to 36 months]
  • Disease Control Rate(DCR) [Time frame: Up to 36 months]
  • Duration of Response (DOR) [Time frame: Up to 36 months]
  • Progression-Free Survival (PFS) [Time frame: Up to 36 months]
  • Overall Survival [Time frame: Up to 36 months]
  • Maximum observed concentration (Cmax) of ABOD2011 [Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product]
  • Area under the concentration-time curve (AUC) of ABOD2011 [Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product]
  • Maximum observed concentration (Cmax) of IL-12 [Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product]
  • Area under the concentration-time curve (AUC) of IL-12 [Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.]
  • Plasma concentration of IFN gamma [Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.]

Eligibility criteria

Inclusion criteria

  • 18 years and older.
  • Understand and voluntarily sign the informed consent form (ICF).
  • Histopathologically confirmed recurrent or metastatic solid tumors.
  • Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
  • Presence of at least one measurable lesion as assessed by RECIST Version 1.1.
  • At least one superficial or deep lesion for intratumoral administration and biopsy.
  • Sufficient organ functions.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Weight > 30 kg.
  • Expected survival longer than 12 weeks.
  • Evidence of menopause in female patients, or for women of childbearing potential: negative for urine or blood pregnancy.

Exclusion criteria

  • Any systemic anti-tumor therapy, within 28 days prior to the first dose.
  • Radiotherapy within 14 days prior to first dose.
  • Use of immunosuppressants.
  • Major surgery within 28 days.
  • Inadequately controlled diseases.
  • Active autoimmune and inflammatory diseases.
  • Clinically symptomatic central nervous system tumors or metastases.
  • Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥ 2.
  • Other malignancies within the previous 5 years with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
  • Active infections.
  • Other conditions that may increase the risk associated with the study drug, or affect the study compliance, etc., which, in the opinion of the investigator, are not suitable for participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT05392699 · ABOD2011-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗