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Not yet recruiting NCT07683832

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

Early Phase I Interventional Non-Small Cell Lung Cancer NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABO2109 and toripalimab.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
  • 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.]
  • 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.]
  • DFS based on RECIST Version 1.1 (Dose Expansion) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07683832 · ABO2109-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗