Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors (NCT07567222) | Clinical Trial Compass
RecruitingPhase 1
Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors
China54 participantsStarted 2026-05-15
Plain-language summary
Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.
Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.
This is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC.
The primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history:
✓. Age 18-75 years.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
✓. Life expectancy \> 3 months.
✓. Adequate organ function within 7 days prior to first dose, including:
✓. At least one measurable or evaluable lesion per RECIST v1.1.
✓. Ability to understand and sign written informed consent and comply with study procedures.
Exclusion criteria
✕. Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.
✕. Active central nervous system (CNS) metastases or leptomeningeal disease.
What they're measuring
1
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Timeframe: From the first dose up to 14 days following the third dose (Day 0 to approximately Day 42).
2
Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to 6 months from the date of the first dose.
✕. Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA \>= 500 IU/mL or \>= 2000 copies/mL).
✕. Active pulmonary tuberculosis.
✕. Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (\> 10 mg/day prednisone equivalent) within 4 weeks prior to first dose.
✕. Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high risk of bleeding or perforation.
✕. Arterial/venous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade \>= 3 bleeding event within 28 days prior to treatment.
✕. Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.