Actively Recruiting
Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors
Led by West China Hospital · Updated on 2026-05-06
54
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced solid tumors or radiologically diagnosed hepatocellular carcinoma
- For osteosarcoma: stable disease or partial response after first-line chemotherapy with at least one lung metastatic lesion ≥ 0.5 cm, or relapsed/progressed after prior chemotherapy
- For pancreatic cancer: disease progression after at least one prior standard systemic therapy
- For head and neck squamous cell carcinoma: disease progression after at least two prior systemic therapies
- For colon cancer: disease progression after at least three prior therapies, including specific chemotherapy agents; RAS wild-type patients must have received EGFR inhibitors
- For hepatocellular carcinoma: disease progression after at least two prior systemic therapies
- For glioma: disease progression after first-line Stupp regimen
- For recurrent metastatic breast cancer: disease progression after at least three prior systemic therapies
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Life expectancy greater than 3 months
- Adequate organ function within 7 days before first dose, including specified blood counts and liver, kidney, and coagulation parameters
- At least one measurable or evaluable lesion per RECIST v1.1
- Ability to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Another primary cancer within 5 years except for treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers
- Active central nervous system metastases or leptomeningeal disease
- Positive for HIV, active hepatitis B or C infection
- Active pulmonary tuberculosis
- Active autoimmune disease requiring systemic treatment within past 2 years or systemic corticosteroids use within 4 weeks before first dose
- Major surgery or significant trauma within 28 days before enrollment or unhealed wounds with bleeding risk
- Arterial/venous thrombosis or pulmonary embolism within 6 months, or severe bleeding events within 28 days before treatment
- Local infection, inflammation, scarring, or coagulation disorders at injection site
- Known hypersensitivity or intolerance to study treatments
- Pregnant, breastfeeding, or planning to conceive during the study
- Any condition that may compromise safety or study participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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