Advanced / Metastatic Solid TumorPhase 1NCT07455617
Study of ABO2102 in KRAS-Mutated Solid Tumors
A Phase 1 study testing ABO2102 Injection and Sintilimab injection in people with Advanced / Metastatic Solid Tumor, run by Suzhou Abogen Biosciences Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced / Metastatic Solid Tumor
- What is being tested?
- ABO2102 Injection and Sintilimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2026to Feb 2030
- Phase
- 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.
- Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
- According to RECIST v1.1, at least one measurable lesion is required.
- No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.
- Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.
Who cannot join
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
- Received KRAS cancer vaccine before.
- History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
- History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- Any active infection (except for hepatitis virus infection) requires systemic treatment.
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- Absence of spleen
- Known psychiatric disorder or drug abuse that may interfere with the trial requirements
- Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
- Other conditions that Investigators consider inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Xinjing Wang, 8618817821319, newvista89@163.com
Baiyong Shen
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors
This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
- Conditions
- Advanced / Metastatic Solid Tumor
- Being tested
- ABO2102 Injection, Sintilimab injection
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO2102 InjectionDrug
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Sintilimab injectionDrug
Anti-PD-1 antibody, administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| ABO2102 Injection | Experimental | Monotherapy Receives: Drug: ABO2102 Injection |
| ABO2102 Injection and Sintilimab Injection | Experimental | ABO2102 Injection in combination with Sintilimab Injection Receives: Drug: ABO2102 Injection; Drug: Sintilimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab
Measured: 28 days after the first dose of study treatment
Part I: Incidence and severity of adverse events
Measured: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy
Part II: ORR evaluated by investigators according to RECIST v1.1 criteria
Measured: from the first dose of study treatment to up to 3 years
Part II: PFS evaluated by investigators according to RECIST v1.1 criteria
Measured: from the first dose of study treatment to up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start24 Mar 2026
- Primary completionJun 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced / Metastatic Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences (Shanghai) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455617
- Sponsor's protocol ID
- ABO2102-102
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors
- ClinicalTrials.gov ID
- NCT07455617
- Acronym / sponsor ID
- ABO2102-102
- Conditions
- Advanced / Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences (Shanghai) Co., Ltd
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 6 Mar 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.
This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABO2102 Injection | Experimental | Drug: ABO2102 InjectionMonotherapy |
| ABO2102 Injection and Sintilimab Injection | Experimental | Drug: ABO2102 Injection, Drug: Sintilimab injectionABO2102 Injection in combination with Sintilimab Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age at time of informed consent.
- Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
- According to RECIST v1.1, at least one measurable lesion is required.
- No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.
Key exclusion criteria (10 listed)
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
- Received KRAS cancer vaccine before.
- History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
- History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
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 |
|---|---|---|
| ABO2102 InjectionmRNA encoding mutant KRAS neoantigens, administrated intramuscularly | Drug | ABO2102 Injection, ABO2102 Injection and Sintilimab Injection |
| Sintilimab injectionAnti-PD-1 antibody, administered intravenously | Drug | ABO2102 Injection and Sintilimab Injection |
Primary outcome
Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab
Time frame: 28 days after the first dose of study treatment
Part I: Incidence and severity of adverse events
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy
Part II: ORR evaluated by investigators according to RECIST v1.1 criteria
Time frame: from the first dose of study treatment to up to 3 years
Part II: PFS evaluated by investigators according to RECIST v1.1 criteria
Time frame: from the first dose of study treatment to up to 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 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 ABO2102 Injection and Sintilimab injection in people with Advanced / Metastatic Solid Tumor, run by Suzhou Abogen Biosciences Co., Ltd. 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 6 inclusion and 10 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 6 Apr 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?
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 Xiao Zhang (8619931100148, xiao.zhang@abogenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab (time frame: 28 days after the first dose of study treatment). 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 6 Apr 2026.