Solid TumorsEarly Phase 1NCT07583953
An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors
A Early Phase 1 study testing ABO2109 Injection;Toripalimab in people with Solid Tumors, run by Suzhou Abogen Biosciences Co., Ltd..
Trial summary
The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ABO2109 Injection;Toripalimab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2026to 17 Apr 2031
- Phase
- Early Phase 1
- 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
- ≥18 years of age at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Life expectancy of ≥6 months
- Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy.
- Sufficient organ function
- Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.
Who cannot join
- For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer
- Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
- Active infections
- History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
- Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab
- Positive pregnancy test or lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
shi hui Fu contact
About this study
Official title: An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.
- Conditions
- Solid Tumors
- Being tested
- ABO2109 Injection;Toripalimab
- Keywords
- The First Affiliated Hospital of Soochow University
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO2109 Injection;ToripalimabBiological
Drug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody
ABO2109 Injection;ToripalimabBiological
Drug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration Part | Experimental | Participants will receive ABO2109 at specified dose defined in the study protocol via an intramuscular (IM) injection every three weeks. The first treatment cycle consists of ABO2109 monotherapy, and combination therapy with toripalimab is initiated from the second treatment cycle onwards. Receives: Biological: ABO2109 Injection;Toripalimab |
| Dose Expansion Part | Experimental | Participants will receive ABO2109 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and Toripalimab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 13 cycles, whichever is sooner. Receives: Biological: ABO2109 Injection;Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration)
Measured: From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration)
Measured: From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
Changes in ECOG performance status score (Dose Exploration)
Measured: From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
DFS based on RECIST Version 1.1. (Dose Expansion)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start17 Apr 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion17 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583953
- Sponsor's protocol ID
- ABO2109-004
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors
- ClinicalTrials.gov ID
- NCT07583953
- Acronym / sponsor ID
- ABO2109-004
- Conditions
- Solid Tumors
- Keywords
- The First Affiliated Hospital of Soochow University
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 17 Apr 2031 (estimated)
- First posted
- 13 May 2026 (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.
The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Exploration Part | Experimental | Biological: ABO2109 Injection;ToripalimabParticipants will receive ABO2109 at specified dose defined in the study protocol via an intramuscular (IM) injection every three weeks. The first treatment cycle consists of ABO2109 monotherapy, and combination therapy with toripalimab is initiated from the second treatment cycle onwards. |
| Dose Expansion Part | Experimental | Biological: ABO2109 Injection;ToripalimabParticipants will receive ABO2109 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and Toripalimab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 13 cycles, whichever is sooner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| ABO2109 Injection;ToripalimabDrug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody | Biological | Dose Exploration Part |
| ABO2109 Injection;ToripalimabDrug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody | Biological | Dose Expansion Part |
Primary outcome
Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration)
Time frame: From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration)
Time frame: From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
Changes in ECOG performance status score (Dose Exploration)
Time frame: From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
DFS based on RECIST Version 1.1. (Dose Expansion)
Time frame: 3 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 13 May 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.
shi hui Fu contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ABO2109 Injection;Toripalimab in people with Solid Tumors, run by Suzhou Abogen Biosciences Co., Ltd..
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Wei Li (+86 15895401045, liwei10@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration) (time frame: From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort). The study lists 4 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 13 May 2026.