Recruiting NCT07680582
An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors
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 Injection, Toripalimab.
- Who it may be relevant to
- Registry conditions: Solid Tumor. 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors
Overview
The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.
Interventions
- Drug ABO2109 Injection
personalized cancer vaccine - Drug 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.]
- Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion) [Time frame: 5 years]
Eligibility 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 solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors
- No evidence of disease progression per investigator within 28 days before the first dose of study intervention
- 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
- 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
- Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
- Presence of 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT07680582 · ABO2109-001