BLESSED: Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast

Pancreatic Cancer Clinical Trial

Official title: BLESSED: Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast

Status Available

Clinical Trial Summary

Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one to three times a week. DeltaRex-G may be given alone or with one or more FDA approved cancer therapies/immunotherapies.

Based on previous Phase 1/2 US based clinical studies, DeltaRex-G 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, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.

Clinical Trial Description

DeltaRex-G 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 augmented drug entry and immune cell trafficking in tumors. 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 DeltaRex-G 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 DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one-three times a week. DeltaRex-G 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, DeltaRex-G 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, DeltaRex-G 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 DeltaRex-G infusions will be held and the patient will be monitored until the toxicity has resolved to <Grade 1, and the patient is stable, after which treatment may be resumed. If the adverse event does not resolve to <Grade 1 within 3 weeks, the DeltaRex-G treatment will be held until the data are discussed with the Food and Drug Administration and a decision is made whether to continue or terminate the study. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma of Breast
• Chondrosarcoma
• Chordoma
• MPNST (Malignant Peripheral Nerve Sheath Tumor)
• Nerve Sheath Neoplasms
• Osteosarcoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Sarcoma
• Soft Tissue Sarcoma

• NCT number: NCT04091295
• Study type: Expanded Access
• Source: Aveni Foundation
• Contact: ERLINDA M GORDON, MD
• Phone: 3105529999
• Email: egordon@sarcomaoncology.com
• Status: Available