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NCT Number: NCT05392699

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Ning Li

CONTACT

Ning Li

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

human single chain IL-12 mRNA-single dose

Biological

human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only

human single chain IL-12 mRNA-multiple dose

Biological

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

Primary outcomes

  1. Number of Participants Experiencing dose-limiting toxicities (DLTs)

    Time frame: From first dose to Day 28

    Number of Participants Experiencing dose-limiting toxicities (DLTs)

  2. 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 Adverse Events (AEs)

  3. 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

    Number of Participants Experiencing Severe Adverse Events (SAEs)

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 36 months

    Overall Response Rate (ORR)

  2. Disease Control Rate(DCR)

    Time frame: Up to 36 months

    Disease Control Rate(DCR)

  3. Duration of Response (DOR)

    Time frame: Up to 36 months

    Duration of Response (DOR)

  4. Progression-Free Survival (PFS)

    Time frame: Up to 36 months

    Progression-Free Survival (PFS)

  5. Overall Survival

    Time frame: Up to 36 months

    Overall Survival

  6. Maximum observed concentration (Cmax) of ABOD2011

    Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product

    Maximum observed concentration (Cmax) of ABOD2011

  7. 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

    Area under the concentration-time curve (AUC) of ABOD2011

  8. Maximum observed concentration (Cmax) of IL-12

    Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product

    Maximum observed concentration (Cmax) of IL-12

  9. 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.

    Area under the concentration-time curve (AUC) of IL-12

  10. Plasma concentration of IFN gamma

    Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.

    Plasma concentration of IFN gamma

Study contacts

Contact information is provided by the study sponsor or research team.

Dawei Wu, Doctor

CONTACT

[email protected]

+8610 87788495

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
May 26, 2022
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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