Not Yet RecruitingEarly Phase 1

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

50 participantsStarted 2026-07-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is still in early Phase 1 and hasn't started recruiting yet — given that it's primarily focused on finding a safe dose rather than proving the vaccine works, is it worth waiting to see if standard post-surgery treatment options might be a better first step for my situation?
2The trial is testing a personalized cancer vaccine called ABO2109, which would be made based on my own tumor's characteristics — how long does that manufacturing process typically take, and could that delay affect my treatment timeline after surgery?
3One of the main things this trial is measuring is dose-limiting toxicity, meaning they're still figuring out how much of this vaccine is safe to give — what kinds of side effects should I realistically be prepared for, especially when it's combined with the immunotherapy drug toripalimab?
4Since my ECOG performance status — basically how well I'm able to carry out daily activities — is one of the things they're tracking as a safety measure, does my current health and activity level make me a realistic candidate to discuss with the trial team?
5Because this trial involves resected NSCLC, meaning it's designed for people who've already had surgery to remove their tumor, how does the timing of when I had or would have surgery factor into whether this trial would even be worth discussing as an option for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy（Dose Exploration)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 3 years

Trial details

NCT IDNCT07683832

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Yongsheng Wang

15150580136 15150580136@163.com

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer NSCLC trials