Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccines Alone and in Combination With Toripalimab in Participants With Resected NSCLC

A Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccine Alone and in Combination With Toripalimab in Patients With Resected NSCLC

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of a personalized cancer vaccine alone and in combination with toripalimab in patients with resected NSCLC. The study included dose escalation and dose expansion two parts.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small Cell Lung Cancer NSCLC
• Intervention / Treatment: Biological: ABO2109 and toripalimab

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yongsheng Wang; Phone Number: 15150580136; Email: 15150580136@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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 NSCLC 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.

Exclusion Criteria:

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABO2109 combined with toripalimab; 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.	Biological: ABO2109 and toripalimab; Biological : ABO2109 Injection personalized cancer vaccine Biological: 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)	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)	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)	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)	3 years

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Suzhou Abogen Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 28, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 17, 2031

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Nanjing Drum Tower Hospital
• Additional Relevant MeSH Terms: toripalimab
• Other Study ID Numbers: ABO2109-003

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