An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors

July 1, 2026 updated by: Ruijin Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. ≥18 years of age at time of informed consent
  2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  3. Life expectancy of ≥6 months
  4. Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors
  5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention
  6. Sufficient organ function
  7. 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.

Key Exclusion Criteria:

  1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
  2. 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
  3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
  4. Presence of active infections
  5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
  6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Exploration Part
For participants in dose exploration, the first treatment cycle consists of ABO2109 monotherapy, and combination therapy with tgripalimab is initiated from the second treatment cycle onwards.For participants in dose expansion,will receive ABO2109 in combination therapy with tgripalimab since the first treatment cycle AB02109 will be administered at specified dose defined in the study protocol via an intramuscular(lM)injection on Day 1 of each 21-day cycle for up to 9 cycles, tgripalimak will be administered via intravenous (lV) infusion on Day 1 of each 21-day cycle until progression,unacceptable toxicity,or up to 13 cycles whichever is sooner.
Drug: ABO2109 Injection
personalized cancer vaccine
Drug: Toripalimab
Anti-PD-1 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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.
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.
Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Suzhou Abogen Biosciences Co., Ltd.

Investigators

  • Principal Investigator: Baiyong Shen, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

February 9, 2031

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABO2109-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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