MedTrace Logo

A Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy and Immunogenicity of a Tumor Vaccine Injection Targeting Stressinducible Proteins MICA/B in Combination With the AG Regimen in Patients With Metastatic Pancreatic Cancer

NCT07231094 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Pancreatic Cancer Metastatic

Interventions

BIOLOGICAL

SapDM275 Tumor Vaccine Injection

SapDM275 tumor vaccine was administered via intramuscular injection on Days 1, 15, and 29, once every two weeks.

Sponsors & Collaborators

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-11-30
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07231094 on ClinicalTrials.gov