Solid Tumor, AdultPhase 1/2NCT06088004
Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors
A Phase 1/2 study testing ABO2011 Injection and Toripalimab in people with Solid Tumor, Adult, run by Suzhou Abogen Biosciences Co., Ltd. at 5 sites in China.
Trial summary
This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- ABO2011 Injection and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 5 sitesChina
- Study dates
- 28 Sep 2023to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Subjects must be ≥18 years olde.
- Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
- Histopathology or cytology confirmed Advanced solid tumors;
- Failed of previous systemic treatment or required treatment histories for selected tumor types;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Expected survival greater than 12 weeks.
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- At least one superficial or deep lesion for intratumoral injection and biopsy.
- Meet the required level of organ function.
- Female patients are postmenopausal or, if women of childbearing potential, have a urine pregnancy or a blood pregnancy that is negative. At the same time, men of childbearing potential and women of childbearing potential voluntarily use effective contraception, including abstinence or effective contraception (e.g., intrauterine or implantable contraceptives, oral contraceptives, injectable or implantable contraceptives, extended-release local contraceptives, intrauterine devices [IUDs], condoms [males], diaphragms, cervical caps, etc.) from the time of signing the ICF until 120 days after the end of treatment.
Who cannot join
- 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 breast, and carcinoma in situ of the cervix.
- Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.
- History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, myocardial infarction within 6 months prior to enrollment, or arrhythmias requiring antiarrhythmic therapy (β-blockers, calcium channel blockers, and digoxin are allowed). QTcF > 480 ms.
- Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and hypoglycemic treatment not Controlled type 2 diabetes, poorly controlled pleural, ascites, or other serious diseases requiring systemic treatment.
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc.; type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy only, and skin diseases that do not require whole body therapy (eg, vitiligo, psoriasis) may be included in the trial.
- The subject carried: Known Human Immunodeficiency Virus (HIV); Active hepatitis B virus infection; Active hepatitis C virus infection.
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- Thrombotic disease or use of full-dose anticoagulant drugs within 6 months prior to screening.
- Radiotherapy within 14 days prior to the first dose.
- Live or live attenuated vaccines or other vaccines within 30 days prior to the first dose may be determined by the investigator's comprehensive assessment.
- Major surgery within 28 days prior to the first dose or non-study-related minor surgery within 14 days prior to the first dose.
- Immunosuppressants or other immunomodulatory medications are required within 4 weeks prior to the first dose, but physiologic doses of systemic steroids are allowed or topical. Topical use should not exceed the dose recommended in the package insert or have any signs of systemic exposure; or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation requiring the use of immunosuppressants or other immunomodulatory drugs.
- Acute toxic effects of prior anticancer chemotherapy or immunotherapy have not been stable, or significant post-treatment toxicities have been observed.
- Any systemic anti-tumor therapy with specific washout windows.
- Presence of clinically significant pulmonary fibrosis or interstitial pneumonia.
- Presence of active infections, including bacteria, fungi, viruses, and tuberculosis.
- Active bleeding, including but not limited to gastrointestinal bleeding, hemoptysis, etc.
- History of immediate severe allergic reactions prior to the first dose.
- Other conditions that may increase the risk associated with the study drug, or affect the study compliance, which the investigator considers unsuitable for participation in the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Ning Li
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Haiqiang Mai
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Song Qu
- Recruiting
Shanxi Cancer hospital
Shanxi
Xin Wang
Guanghua Mao
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen
Yan Qin
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK/PD) and Preliminary Efficacy of ABO2011 Monotherapy or in Combination With Toripalimab in Patients With Advanced Solid Tumors
This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult
- Being tested
- ABO2011 Injection, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO2011 InjectionDrug
Also called ABO2011, ABOD2011
Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection
ToripalimabDrug
Anti-PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| ABO2011 | Experimental | Monotherapy Receives: Drug: ABO2011 Injection |
| ABO2011 and Toripalimab | Experimental | Combination therapy Receives: Drug: ABO2011 Injection; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence and character of DLTs
Measured: monotherapy: 21 days after the first dose. Combination therapy: 28 days after the first dose]
Phase I: Incidence of Adverse Event (AE)
Measured: monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.
Phase I: Incidence of Serious Adverse Event (SAE)
Measured: monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.]
Phase I: Incidence of patients with clinically significant abnormal laboratory results
Measured: monotherapy: from the first dose until 28 days of last administration. Combination therapy: from informed consent until 90 days after the last administration.
Phase II: Objective response rates
Measured: Estimated to be from time of informed consent up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start28 Sep 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abogen Life Sciences (Shanghai) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ning Li, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088004
- Sponsor's protocol ID
- ABO2011-103
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK/PD) and Preliminary Efficacy of ABO2011 Monotherapy or in Combination With Toripalimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06088004
- Acronym / sponsor ID
- ABO2011-103
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Abogen Life Sciences (Shanghai) Co., Ltd.
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Oct 2023 (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.
This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABO2011 | Experimental | Drug: ABO2011 InjectionMonotherapy |
| ABO2011 and Toripalimab | Experimental | Drug: ABO2011 Injection, Drug: ToripalimabCombination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be ≥18 years olde.
- Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
- Histopathology or cytology confirmed Advanced solid tumors;
- Failed of previous systemic treatment or required treatment histories for selected tumor types;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (18 listed)
- 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 breast, and carcinoma in situ of the cervix.
- Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.
- History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, myocardial infarction within 6 months prior to enrollment, or arrhythmias requiring antiarrhythmic therapy (β-blockers, calcium channel blockers, and digoxin are allowed). QTcF > 480 ms.
- Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and hypoglycemic treatment not Controlled type 2 diabetes, poorly controlled pleural, ascites, or other serious diseases requiring systemic treatment.
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc.; type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy only, and skin diseases that do not require whole body therapy (eg, vitiligo, psoriasis) may be included in the trial.
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 |
|---|---|---|
| ABO2011 InjectionAlso: ABO2011, ABOD2011Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection | Drug | ABO2011, ABO2011 and Toripalimab |
| ToripalimabAnti-PD-1 antibody | Drug | ABO2011 and Toripalimab |
Primary outcome
Phase I: Incidence and character of DLTs
Time frame: monotherapy: 21 days after the first dose. Combination therapy: 28 days after the first dose]
Phase I: Incidence of Adverse Event (AE)
Time frame: monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.
Phase I: Incidence of Serious Adverse Event (SAE)
Time frame: monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.]
Phase I: Incidence of patients with clinically significant abnormal laboratory results
Time frame: monotherapy: from the first dose until 28 days of last administration. Combination therapy: from informed consent until 90 days after the last administration.
Phase II: Objective response rates
Time frame: Estimated to be from time of informed consent up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Ning Li principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABO2011 Injection and Toripalimab in people with Solid Tumor, Adult, run by Suzhou Abogen Biosciences Co., Ltd. at 5 sites 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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nong Chen (010-57593072, nong.chen@abogenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence and character of DLTs (time frame: monotherapy: 21 days after the first dose. Combination therapy: 28 days after the first dose]). The study lists 5 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 23 Sep 2026.