Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x10e10 RV copies per dose one to three times a week. DNG64 may be given alone or with oneor more FDA approved cancer therapies/immunotherapies.Based on previous Phase 1/2 US based clinical studies, DNG64 does not suppress the bonemarrow or cause organ dysfunction, and enhanced immune cell trafficking in tumors maycause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further,tumor stabilization/regression/remission may occur later during the treatment period.Therefore, DNG64 will be continued regardless of CT, PET or MRI results if the patienthas clinical benefit and does not have symptomatic disease progression.
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 inhibitor gene for killing cancer cells, its blood supply and stroma
producing fibroblasts, thus reducing extracellular matrix production and augmenting drug
entry and immune cell trafficking in tumor microenvironment. Enhanced CCNG1 expression
has been found in all cancer types tested at the Cancer Center of Southern California as
of June 2023. Hence, in July 2023, the USFDA authorized the use of DNG64 as platform
therapy upon which one or more FDA approved cancer drugs/ immunotherapies may be added.
This would allow a personalized approach in the treatment of all cancer patients.
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 dose one-three times a week. DNG64 may be given alone or with an FDA
approved cancer therapy/immunotherapy on physician discretion.
Based on previous Phase 1/2 US based clinical studies, DNG64 does not suppress the bone
marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors
may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI.
Further, tumor stabilization/regression/remission may occur later during the treatment
period. Therefore, DNG64 will be continued regardless of CT, PET or MRI results if the
patient has clinical benefit and does not have symptomatic disease progression.
If the patient develops a treatment-related >Grade 3 adverse event, the DNG64 infusions
will be held and the patient will be monitored until the toxicity has resolved to
does not resolve to
to continue or terminate the study.
Drug: DNG64
Intravenous infusions of DNG64 for treatment of advanced pancreatic cancer, sarcoma and
carcinoma of breast
Other Name: DNG64 Chimeric Amphotroopic RNA Vector Encoding a Cyclin G1 Inhibitor
Inclusion Criteria:
- 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 Criteria:
- 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
Sarcoma Oncology Research Center, LLC
Santa Monica, California, United States
Investigator: ERLINDA M GORDON, MD
Contact: 310-552-9999
egordon@sarcomaoncology.com
ERLINDA M GORDON, MD
3105529999
egordon@sarcomaoncology.com
Victoria Chua-Alcala, MD
3105529999
vchua@sarcomaoncology.com
ERLINDA M GORDON, MD, Principal Investigator
Sarcoma Oncology Research Center, LLC