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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 1

Conditions: Patients With Advanced Solid Tumors

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05392699

ABOD2011-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Human single chain IL-12 mRNA-single dose

Experimental group

Description:

Human single chain IL-12 mRNA-single dose

Treatment:

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

Human single chain IL-12 mRNA-multiple dose

Experimental group

Description:

Human single chain IL-12 mRNA-multiple dose

Treatment:

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