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

Phase 1

Recruiting

• Conditions: Patients With Advanced Solid Tumors
• Interventions: Biological: human single chain IL-12 mRNA-single dose; Biological: human single chain IL-12 mRNA-multiple dose

• Registration Number: NCT05392699
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-05-23
• Study Start: 2022-05-25
• Study First Posted: 2022-05-26
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-19
• Last Update Posted: 2022-06-22
• Primary Completion: 2025-03
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human single chain IL-12 mRNA-single dose	human single chain IL-12 mRNA-single dose	Human single chain IL-12 mRNA-single dose
Human single chain IL-12 mRNA-multiple dose	human single chain IL-12 mRNA-multiple dose	Human single chain IL-12 mRNA-multiple dose

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing dose-limiting toxicities (DLTs)	From first dose to Day 28	Number of Participants Experiencing dose-limiting toxicities (DLTs)
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 Adverse Events (AEs)
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	Number of Participants Experiencing Severe Adverse Events (SAEs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China