ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy
NCT ID: NCT05392699
Last Updated: 2022-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2022-05-25
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 administered as specified in the treatment arm with injection once only
Human single chain IL-12 mRNA-multiple dose
Human single chain IL-12 mRNA-multiple dose
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Ning Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Ning Li
Role: primary
Other Identifiers
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ABOD2011-001
Identifier Type: -
Identifier Source: org_study_id
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