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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Advanced Solid Tumors
• Intervention / Treatment: Biological: human single chain IL-12 mRNA-single dose; Biological: human single chain IL-12 mRNA-multiple dose

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dawei Wu, Doctor; Phone Number: +8610 87788495; Email: wumingshi-117@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Principal Investigator: Ning Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Any systemic anti-tumor therapy, within 28 days prior to the first dose.
2. Radiotherapy within 14 days prior to first dose.
3. Use of immunosuppressants.
4. Major surgery within 28 days.
5. Inadequately controlled diseases.
6. Active autoimmune and inflammatory diseases.
7. Clinically symptomatic central nervous system tumors or metastases.
8. Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥ 2.
9. 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.
10. Active infections.
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human single chain IL-12 mRNA-single dose	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
Experimental: Human single chain IL-12 mRNA-multiple dose	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall Response Rate (ORR)	Up to 36 months
Disease Control Rate(DCR)	Disease Control Rate(DCR)	Up to 36 months
Duration of Response (DOR)	Duration of Response (DOR)	Up to 36 months
Progression-Free Survival (PFS)	Progression-Free Survival (PFS)	Up to 36 months
Overall Survival	Overall Survival	Up to 36 months
Maximum observed concentration (Cmax) of ABOD2011	Maximum observed concentration (Cmax) of ABOD2011	From first dose of ABOD2011 through to 28 days after last dose of investigational product
Area under the concentration-time curve (AUC) of ABOD2011	Area under the concentration-time curve (AUC) of ABOD2011	From first dose of ABOD2011 through to 28 days after last dose of investigational product
Maximum observed concentration (Cmax) of IL-12	Maximum observed concentration (Cmax) of IL-12	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	Area under the concentration-time curve (AUC) of IL-12	From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Plasma concentration of IFN gamma	Plasma concentration of IFN gamma	From first dose of ABOD2011 through to 28 days after last dose of investigational product.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Ning Li, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Adjuvants, Immunologic; Interleukin-12
• Other Study ID Numbers: ABOD2011-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No