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

NCT07683832 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ABO2109-003
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer NSCLC

Keywords

Nanjing Drum Tower Hospital

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

ABO2109 combined with toripalimab

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.

Biological: ABO2109 and toripalimab

Interventions

ABO2109 and toripalimab BIOLOGICAL

Biological : ABO2109 Injection personalized cancer vaccine Biological: Toripalimab Anti-PD-1 monoclonal antibody

ABO2109 combined with toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Yongsheng Wang

CONTACT

15150580136; 15150580136@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: July 6, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 17, 2031
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share