Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants will receive VG2025 intraperitoneally over about 5 minutes on Days 1-3 of each 21-day cycle. Participants will be watched for side effects for about 2 hours after each dose.

Up to 3 dose levels of VG2025 will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of VG2025 given intraperitoneally is found.

VG2025

Siqing Fu, MD,PHD

To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors.

Primary Objectives

1. To assess safety and tolerability of VG2025 following IP administration
2. To determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of IP VG2025

Secondary Objectives

1. To estimate progression free survival
2. To characterize the biodistribution or shedding profile of detectable VG2025 DNA in tumor (biopsy samples), IP fluid, and blood
3. To evaluate IL-12, IL-15, and other cytokine levels in tumor (biopsy samples), IP fluid, and blood
4. To evaluate tumor CEA expression
5. To evaluate the objective response rate (ORR) and clinical benefit rate (CBR) of IP administration of VG2025 in the overall patient population and by dose level
6. To characterize changes in the IP and tumor immune microenvironment in response to treatment
7. To correlate circulating tumor DNA (ctDNA) with disease status

Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis

Phase I Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

M.D. Anderson Cancer Center

Rare Diseases

Neuroendocrine Tumors

Neuroendocrine Tumor

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

This is an open label trial using standard 3+3 design, in up to 24 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients.

The starting dose of VG2025 in the combination cohorts will be a dose level lower than RP2D of monotherapy arm and Nivolumab will be administered intravenously as a flat dose of 240 mg every two weeks.

1. 1.0×108PFU Day 1 and 15
2. 2.0×108PFU Day 1 and 15
3. 3.0×108PFU Day 1 and 15
4. 4.0×108PFU Day 1 and 15

Nivolumab Injection [Opdivo]

Cherrise Brownson

Madappa Kundranda, MD

Siqing Fu

This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. All patients within a given dose level cohort will be treated with the same dose schedule of VG2025, administered as bi-weekly intratumoral injections at Day 1 and Day 15. Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment, Day 1, through Day 28.

There are two parts to this study a monotherapy arm and a combination therapy arm. In the monotherapy arm the patients will receive VG2025 only. In the combination therapy arm the patients will receive VG2025 and Nivolumab

Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors

Incidence of Adverse Events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)

evaluate the interleukin (IL)-12 and IL-15 in injected tumor (biopsy samples) and blood

Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

Duration of response (DoR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

Disease control rate (DCR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

Progression-free survival (PFS), based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis	NCT06365918	Advanced Solid ... Carcinomatosis	VG2025	18 Years -	M.D. Anderson Cancer Center
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors	NCT05266612	Solid Tumor	VG2025 Nivolumab Injec...	18 Years -	Virogin Biotech Ltd.
Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis	NCT06365918	Advanced Solid ... Carcinomatosis	VG2025	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for vg2025

Every month we try and update this database with for vg2025 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vg2025

Every month we try and update this database with for vg2025 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vg2025 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.