Study design:
This is a single-arm, open-label, dose-escalation and dose-expansion clinical study to evaluate the safety and efficacy of multiple doses of SapDM275 tumor vaccine injection in combination with the AG regimen for the treatment of patients with metastatic pancreatic cancer who have not received prior systemic anti-cancer therapy and are planned to receive AG as first-line treatment.
Treatment must be initiated within 7 days after enrollment. Patients will receive intramuscular injections of SapDM275 tumor vaccine combined with AG regimen until the occurrence of any of the following: disease progression, intolerable toxicity, death (whichever occurs first), the investigator's assessment that the subject is no longer suitable for further treatment, or withdrawal of consent by the subject.
Age ≥18 years;
Histologically or cytologically confirmed unresectable metastatic pancreatic cancer;
No prior systemic anti-tumor therapy for metastatic pancreatic cancer. Neoadjuvant or adjuvant therapy is permitted, provided no disease progression occurred within 6 months after the last administration;
At least one measurable lesion according to RECIST v1.1 criteria;
History of other malignancies within 5 years prior to screening, except for cancers with negligible risk of metastasis or death (5-year recurrence-free survival >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I endometrial cancer.
Active infections requiring treatment, including active HBV or HCV infection; known HIV infection or history of AIDS; active tuberculosis.
Toxicities from prior anti-tumor therapies not resolved to grade ≤2 per NCI-CTCAE v5.0 (or higher version) or baseline, except for alopecia and skin hyperpigmentation (any grade allowed).
Receipt of a live vaccine within 28 days prior to the first study treatment or planned receipt of a live vaccine during the study.
Sequential
SapDM275 Tumor Vaccine Injection
Biological/VaccineSapDM275 tumor vaccine was administered via intramuscular injection on Days 1, 15, and 29, once every two weeks.
adverse events
Frequency, number, incidence, and severity of the adverse events and adverse reactions
Objective response rate (ORR)
Objective response rate will be estimated by CT or MRI depending on the cancer type and location, according to RESIST V1.1.
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