Clinical trial · Interventional
An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors
An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors
NCT07680582CI-TRIAL-00120274recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABO2109 Injection | Drug | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Exploration Part
- description
- For participants in dose exploration, the first treatment cycle consists of ABO2109 monotherapy, and combination therapy with tgripalimab is initiated from the second treatment cycle onwards.For participants in dose expansion,will receive ABO2109 in combination therapy with tgripalimab since the first treatment cycle AB02109 will be administered at specified dose defined in the study protocol via an intramuscular(lM)injection on Day 1 of each 21-day cycle for up to 9 cycles, tgripalimak will be administered via intravenous (lV) infusion on Day 1 of each 21-day cycle until progression,unacceptable toxicity,or up to 13 cycles whichever is sooner.
- interventionNames
- Drug: ABO2109 Injection
- Drug: Toripalimab
Primary outcomes (4)
- measure
- Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration)
- timeFrame
- From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
- measure
- Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.