Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT07231094
Brief Summary:
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.
Detailed Description:
The dose escalation stage inclues two dose cohorts: 5×10⁶active particles and 5×10⁷active particles. Subjects in each cohort will receive a fixed dose via intramuscular injection on Day 1, Day 15, and Day 29.
The traditional3+3 dose-escalation design will be applied:
Three subjects will be enrolled in each cohort. If no dose-limiting toxicity (DLT) is observed during the 35-day observation period, escalation to the next dose level will proceed.
If two or more subjects experience DLTs, dose escalation will be terminated. If one subject experiences a DLT, three additional subjects will be enrolled at the same dose level.
If no DLT occurs in these additional three subjects, escalation to the next dose level will proceed.
If one DLT occurs among the additional three subjects, dose escalation will be terminated.
Dose expansion stage When the high-dose group (5×107 active particles group) in the dose escalation stage achieve good safety profile, a further expansion stage is expected includes a total of approximately 10 subjects (including those in the dose escalation stage).
When ≥2/6 of the patients in the high-dose group (5×107 active particles group) developed DLT during the dose escalation stage, further expansion will return to the low-dose group (5×106 active particles group). The low-dose group could reach a total of approximately 10 subjects (including subjects in the dose escalation stage).
Study:
NCT07231094
Study Brief:
Protocol Section:
NCT07231094