An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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
Qualifiers
≥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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ABO2109 Injection
- Toripalimab
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
1Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine200025, ShanghaiShanghai Municipality, China
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
Suzhou Abogen Biosciences Co., Ltd.
Collaborator
Source ClinicalTrials.gov