Patients With Advanced Solid Tumors
Conditions
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.
Interventions
BIOLOGICALhuman single chain IL-12 mRNA-single dose
human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only
BIOLOGICALhuman 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
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall Response Rate (ORR) | Up to 36 months | Overall Response Rate (ORR) |
| 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 |
| 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 |
| Disease Control Rate(DCR) | Up to 36 months | Disease Control Rate(DCR) |
| Duration of Response (DOR) | Up to 36 months | Duration of Response (DOR) |
Countries
China
Contacts
Primary ContactDawei Wu, Doctor
Outcome results
None listed