Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07680582

An Exploratory Study of Personalized Cancer Vaccine 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Xinjing Wang

CONTACT

[email protected]

18817821319

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • ≥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, or patients with advanced solid tumors
  • No evidence of disease progression per investigator within 28 days before the first dose of study intervention
  • 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.

Key Exclusion Criteria:

  • 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
  • Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
  • Presence of 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.

Treatment and study plan

ABO2109 Injection

Drug

personalized cancer vaccine

Toripalimab

Drug

Anti-PD-1 monoclonal antibody

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion)

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xinjing Wang

CONTACT

[email protected]

18817821319

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Suzhou Abogen Biosciences Co., Ltd.

Registry information

Official study title

An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors

Important dates

Study start
2026
Primary completion
2026
Study completion
2031
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.