NCT07680582 An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors
| NCT ID | NCT07680582 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Ruijin Hospital |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-06-09 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: 1. ≥18 years of age at time of informed consent 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 3. Life expectancy of ≥6 months 4. Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors 5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention 6. Sufficient organ function 7. 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. Key Exclusion Criteria: 1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously 2. 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 3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function. 4. Presence of active infections 5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment 6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.
Contact & Investigator
Baiyong Shen
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT07680582 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07680582 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07680582 currently recruiting?
Yes, NCT07680582 is actively recruiting participants. Contact the research team at newvista89@163.com for enrollment information.
Where is the NCT07680582 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07680582 clinical trial?
NCT07680582 is sponsored by Ruijin Hospital. The principal investigator is Baiyong Shen at Ruijin Hospital. The trial plans to enroll 60 participants.