NCT07683832Not 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
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Apr 2026
- Start date
- 28 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Lung cancer
- NCT number
- NCT07683832
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 50
- From 28 Jul 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
- Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
- History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
Other illness
- 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 infections
- Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab
Other
- Positive pregnancy test or lactating women
Who the study is looking for
- ≥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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.