Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer, Osteosarcoma, Soft Tissue Sarcoma and Carcinoma of Breast

Study Overview
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Brief Summary
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Forty patients with advanced pancreatic cancer, osteosarcoma, soft tissue sarcoma, and breast cancer 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 or may not be given 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.

Detailed Description
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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, a CCNG1 inhibitor, 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 patients with advanced cancer who have failed standard therapies. Forty patients with advanced pancreatic cancer, osteosarcoma, soft tissue sarcoma, and breast cancer 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 or may not be given 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.

Official Title
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BLESSED: Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer,Osteosarcoma, Soft Tissue Sarcoma and Carcinoma of Breast

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

Intervention / Treatment
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* Drug: DeltaRex-G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥12 years of age, either male or female. Patient has advanced metastatic pancreatic cancer or advanced metastatic sarcoma 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DeltaRex-G|Intravenous infusions of DeltaRex-G for treatment of advanced pancreatic cancer and sarcoma that have failed standard therapies|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor targeted gene therapy, human cyclin G1 inhibitor, cell cycle control, CCNG1 inhibitor