Status:
AVAILABLE
BLESSED: Expanded Access for DNG64 for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast
Lead Sponsor:
Aveni Foundation
Conditions:
Pancreatic Cancer
Osteosarcoma
Eligibility:
All Genders
12-100 years
Brief Summary
Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64 intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x 10e10 RV copies per ...
Detailed Description
DNG64 is a targeted tumor agnostic gene therapy that displays a Sig-binding peptide for binding to abnormal collagenous Signature (Sig) proteins in the tumor microenvironment and encoding a CCNG1 inhi...
Eligibility Criteria
Inclusion
- Patient is ≥12 years of age, either male or female for patients with sarcoma; \>18 years of age, either male or female.with pancreatic cancer or carcinoma of breast.
- Patient has pancreatic cancer or sarcoma or carcinoma of breast confirmed by pathologic examination at diagnosis.
- Patients with advanced metastatic pancreatic cancer who have received systemic therapies such as FOLFIRINOX and gemcitabine + albumin-bound paclitaxel; patients with metastatic sarcoma who have disease progression after two or more lines of systemic treatments and not amenable to surgical resection or radiotherapy; specifically for osteosarcoma: have disease progression after high dose methotrexate, cisplatinum, doxorubicin and ifosfamide; for soft tissue sarcoma: have disease progression after doxorubicin + ifosfamide/mesna, gemcitabine, docetaxel, dacarbazine, trabectedin, pazopanib, eribulin; patients with metastatic carcinoma of breast who have disease progression with standard therapy (ACT), targeted therapies including aromatase inhibitors, trastuzumab, pertuzumab, enhertu, tyrosine kinase inhibitors, immune checkpoint inhibitors; patient who is intolerant to or declines available therapeutic options after documentation that patient has been informed of the available therapeutic options.
- Patient is able to understand or is willing to sign a written informed consent.
- Patient agrees to use barrier contraception during vector infusion period and for 6 weeks after infusion
Exclusion
- Patient is unwilling to provide formal informed consent.
- Patient is unwilling to use barrier contraception during vector infusion period and for 6 weeks after infusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04091295
Last Update
February 24 2025
Active Locations (1)
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1
Sarcoma Oncology Research Center, LLC
Santa Monica, California, United States, 90403