Patients With Advanced Solid TumorsPhase 1NCT05392699
ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy
A Phase 1 study testing human single chain IL-12 mRNA-single dose and human single chain IL-12 mRNA-multiple dose in people with Patients With Advanced Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- human single chain IL-12 mRNA-single dose and human single chain IL-12 mRNA-multiple dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 9 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older.
- Understand and voluntarily sign the informed consent form (ICF).
- Histopathologically confirmed recurrent or metastatic solid tumors.
- Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
- Presence of at least one measurable lesion as assessed by RECIST Version 1.1.
- At least one superficial or deep lesion for intratumoral administration and biopsy.
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- Sufficient organ functions.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Weight > 30 kg.
- Expected survival longer than 12 weeks.
- Evidence of menopause in female patients, or for women of childbearing potential: negative for urine or blood pregnancy.
Who cannot join
- Any systemic anti-tumor therapy, within 28 days prior to the first dose.
- Radiotherapy within 14 days prior to first dose.
- Use of immunosuppressants.
- Major surgery within 28 days.
- Inadequately controlled diseases.
- Active autoimmune and inflammatory diseases.
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- Clinically symptomatic central nervous system tumors or metastases.
- Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥ 2.
- 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.
- Active infections.
- 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 locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: 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.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- human single chain IL-12 mRNA-single dose, human single chain IL-12 mRNA-multiple dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human single chain IL-12 mRNA-single doseBiological
human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only
human single chain IL-12 mRNA-multiple doseBiological
human single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Human single chain IL-12 mRNA-single dose | Experimental | Human single chain IL-12 mRNA-single dose Receives: Biological: human single chain IL-12 mRNA-single dose |
| Human single chain IL-12 mRNA-multiple dose | Experimental | Human single chain IL-12 mRNA-multiple dose Receives: Biological: human single chain IL-12 mRNA-multiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Measured: From first dose to Day 28
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Adverse Events (AEs)
Measured: 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)
Measured: From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months
Secondary outcomes (10)
Overall Response Rate (ORR)
Overall Response Rate (ORR)
Measured: Up to 36 months
Disease Control Rate(DCR)
Disease Control Rate(DCR)
Measured: Up to 36 months
Duration of Response (DOR)
Duration of Response (DOR)
Measured: Up to 36 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: Up to 36 months
Overall Survival
Overall Survival
Measured: Up to 36 months
Maximum observed concentration (Cmax) of ABOD2011
Maximum observed concentration (Cmax) of ABOD2011
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 May 2022
- Primary completion9 Dec 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392699
- Sponsor's protocol ID
- ABOD2011-001
- Status last verified
- Jun 2022
- First submitted
- 15 Mar 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05392699
- Acronym / sponsor ID
- ABOD2011-001
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human single chain IL-12 mRNA-single dose | Experimental | Biological: human single chain IL-12 mRNA-single doseHuman single chain IL-12 mRNA-single dose |
| Human single chain IL-12 mRNA-multiple dose | Experimental | Biological: human single chain IL-12 mRNA-multiple doseHuman single chain IL-12 mRNA-multiple dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years and older.
- Understand and voluntarily sign the informed consent form (ICF).
- Histopathologically confirmed recurrent or metastatic solid tumors.
- Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
- Presence of at least one measurable lesion as assessed by RECIST Version 1.1.
Key exclusion criteria (11 listed)
- Any systemic anti-tumor therapy, within 28 days prior to the first dose.
- Radiotherapy within 14 days prior to first dose.
- Use of immunosuppressants.
- Major surgery within 28 days.
- Inadequately controlled diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human single chain IL-12 mRNA-single dosehuman single chain IL-12 mRNA administered as specified in the treatment arm with injection once only | Biological | Human single chain IL-12 mRNA-single dose |
| human single chain IL-12 mRNA-multiple dosehuman single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks | Biological | Human single chain IL-12 mRNA-multiple dose |
Primary outcome
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Time frame: From first dose to Day 28
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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)
Time frame: 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)
10 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 36 months
Disease Control Rate(DCR)
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival
Time frame: Up to 36 months
Maximum observed concentration (Cmax) of ABOD2011
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
Area under the concentration-time curve (AUC) of ABOD2011
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
Maximum observed concentration (Cmax) of IL-12
Time frame: 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
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Plasma concentration of IFN gamma
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human single chain IL-12 mRNA-single dose and human single chain IL-12 mRNA-multiple dose in people with Patients With Advanced Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing dose-limiting toxicities (DLTs) (time frame: From first dose to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.