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

NCT05392699 | Recruiting Phase 1

• 1 other identifier: ABOD2011-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Patients With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing dose-limiting toxicities (DLTs)

  Number of Participants Experiencing dose-limiting toxicities (DLTs)

  From first dose to Day 28

• Number of Participants Experiencing Adverse Events (AEs)

  Number of Participants Experiencing Adverse Events (AEs)

  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)

  Number of Participants Experiencing Severe Adverse Events (SAEs)

  From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months

Secondary Outcomes (10)

• Overall Response Rate (ORR)

  Up to 36 months

• Disease Control Rate(DCR)

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Progression-Free Survival (PFS)

  Up to 36 months

• Overall Survival

  Up to 36 months

Study Arms (2)

Human single chain IL-12 mRNA-single dose

EXPERIMENTAL

Human single chain IL-12 mRNA-single dose

Biological: human single chain IL-12 mRNA-single dose

Human single chain IL-12 mRNA-multiple dose

EXPERIMENTAL

Human single chain IL-12 mRNA-multiple dose

Biological: human single chain IL-12 mRNA-multiple dose

Interventions

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-single dose

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

Human single chain IL-12 mRNA-multiple dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Study Officials

• Ning Li, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawei Wu, Doctor

CONTACT

+8610 87788495; wumingshi-117@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: May 26, 2022
• Study Start: May 25, 2022
• Primary Completion: March 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

CN (1)