YNP01 trial
- Conditions
- patients with advanced or metastatic solid cancer
- Registration Number
- JPRN-jRCTs061180058
- Lead Sponsor
- agano Hiroaki
- Brief Summary
This phase I study evaluated the safety, peptide-specific CTL, and antitumor effects of a novel vaccination therapy comprising multi-HLA-binding HSP70/GPC3 peptides and adjuvants of LAG-3Ig and Poly-ICLC against gastrointestinal cancers. Seventeen patients received therapy without DLT. Peptide-specific CTL induction by HSP70 and GPC3 proteins was observed in 11 and 13 cases. Tumor markers were decreased in 10 cases. This novel peptide vaccination therapy was safe and effective for patients with GI cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 17
1.patients with advanced or metastatic solid cancer (Pancreatic cancer, colon cancer, gastric cancer, esophageal cancer, liver cancer and breast cancer) proven by histology or imaging (CT or MRI)
2. Patients with HLA-A*2402 -A*0201 -A*0206
3. Standard treatment failure cancer
4. Age; 20>=
5. Performance Status (PS); 0-1, Eastern Cooperative
Oncology Group (ECOG)
6. Preserved organ functions (number of WBCs more than
2.0x103/mm3; % of lymphocyte >=15; number of platelets
>=7.5x103/mm3; hemoglobin >=8.0 g/ dl; creatinine <=2.5
times of upper normal limit)
7.Patients provided written, informed consent to participate
The exclusion criteria were, double cancer, pneumonitis, severe allergy, severe infection, neurological disturbance, uncontrolled general diseases, heart diseases, general steroid treatment, or any prior therapies using same agents of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method