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Submitted by: Mrs. Nina Dalisay Bauzon 2016-08-18 00:00:00 Last Updated by: Mrs. Nina Dalisay Bauzon 2021-03-12 10:59:36


GenVivo / EPB-002

PHRR160819-001346

PROTOCOL NUMBER: EPB-002

2013-CT0160

A Phase 1 Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GEN2 (HSV- Thymidine Kinase-m2 and hGM-CSF Genes) in Refractory Patients with Primary Hepatocellular Carcinoma or Tumors Metastatic to the Liver

This clinical trial will be divided into two phases: Phase IA in which the dose, route, and schedule of the GEN2 administration is determined and Phase IB which is designed to explore the activity of GEN2 in patients of a defined or several defined tumor types and stages based on the Phase IA data and who are [18F]FHBG scan positive approximately three to six days after one dose (RP2D) of GEN2.Based on safety data accumulated over the first 22 patients, Phase IA is divided into three routes of administration in order to investigate the optimal route of administration: (a) Phase IA.1 which explores peripheral IV infusion; (b) Phase IA.2 which investigates hepatic arterial infusion and (c) Phase IA.3 which examines intratumoral delivery.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2014-06-13 102 2022-12-13 0000-00-00

Ongoing

Institution Classification Region LTO #
GenVivo, Inc. Private Business United States of America Not applicable
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Region
GenVivo, Inc. United States of America
Name E-Mail Institution and Institution Address
Jennifer Olive Arellano jenny.arellano@novotech-cro.com Unit A & D, 5th Floor, Rockwell Business Tower 1, Rockwell Business Center, Ortigas Avenue, Baranggay Ugong, Pasig Metro Manila 1604 Philippines
Name E-Mail Institution and Institution Address
Jennifer Olive Arellano jenny.arellano@novotech-cro.com Unit A & D, 5th Floor, Rockwell Business Tower 1, Rockwell Business Center, Ortigas Avenue, Baranggay Ugong, Pasig Metro Manila 1604 Philippines
Name Expertise Affiliation
John P. Querol, MD Medical Oncology The Medical City
Maria Belen E. Tamayo, MD Medical Oncology Makati Medical Center
Necy Juat, MD Medical Oncology National Kidney and Transplant Institute
Priscilla B. Caguioa, MD Medical Oncology St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
The Medical City The Medical City - Institutional Review Board
Makati Medical Center Makati Medical Center Institutional Review Board
National Kidney and Transplant Institute National Kidney and Transplant Institute Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

Patients with Primary Hepatocellular Carcinoma or Tumors Metastatic to the Liver

To determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety, and a Recommended Phase 2 Dose (RP2D) of GEN2 administered over a three week cycle consisting of (a) a series of three doses given intravenously within five days by peripheral IV infusion; or (b) a series of two doses given over 2 days given via intra-hepatic artery infusion; or (c) one intratumoral injection in week 1, followed by 5 daily doses of valganciclovir in week 2 in patients enrolled in this study who have been diagnosed with advanced primary or metastatic tumors to the liver.

To evaluate the plasma pharmacokinetics of GEN2. To assess the surrogate of HSV-TK-m2 protein expression from GEN2 via serial [18F]FHBG PET and/or SPECT imaging. To describe and assess any preliminary evidence of anti-tumor activity of GEN2. To provide clinical research testing for antibodies to retrovector gp70 env, replication-competent retrovirus in peripheral blood lymphocytes (PBLs); vector integration into genomic DNA of PBLs, and circulating hGM-CSF protein.

Recruiting

  • Philippines

Clinical Trial

PROTOCOL NUMBER: EPB-002

2013-CT0160

2014-02-18

0000-00-00

154

154

Unspecified

13 Jun 2014

Patient Inclusion Criteria: 1. Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors in the liver that are refractory to standard therapy or for which no curative standard therapy exists. 2. Evidence of radiographically measurable or evaluable disease on a baseline PET-CT scan. 3. All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Version 4.03) Grade 18 years. 5. Last dose of antineoplastic therapy, except for hormonal therapy, must be > 21 days. External beam radiotherapy must have been Patients may have intracranial metastases of any number if they have been brain irradiated and stable for 6 weeks. Patients may be taking anti-seizure medicines but must not be on steroids. 8. Karnofsky performance status must be ≥ 70. 9. Life expectancy of at least 3 months. 10. Patients must be able to travel to St. Luke’s Medical Center for the PET scans. 11. Required baseline laboratory data  12. Signed informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. 13. Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.   Patient Exclusion Criteria: 1. Concurrent therapy with any anticancer therapy including any other investigational agent. 2. Known existing intracranial edema or a CVA within 6 weeks of screening. 3. Pregnant or breast-feeding women. Female patients must agree to use effective contraception, must be surgically sterile or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate. All at-risk female patients must have a negative pregnancy test within 7 days prior to the start of study treatment. 4. Clinically significant cardiac disease (New York Heart Association, Class III or IV). 5. Dementia or altered mental status that would prohibit informed consent. 6. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study. 7. Known side effects to antivirals in the ganciclovir class. 8. Patients who are known to be HIV positive. 9. Patient must not be taking steroids at the time of screening.

Interventional

GEN2 (HSV-Thymidine Kinase-m2 and hGM-CSF genes)

GEN2 is a Moloney Murine replication incompetent retrovector particle containing the genes encoding for a HSV-TK-m2 and hGM-CSF.

Date Amendment Classification Reason
2019-01-18 Amendments related to the protocol Number of participants
2020-02-18 Amendments related to the IND Change of IP name

Unspecified

Open Label

Unspecified

Unspecified

To determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety, and a Recommended Phase 2 Dose (RP2D) of GEN2 administered over a three week cycle consisting of (a) a series of three doses given intravenously within five days by peripheral IV infusion; or (b) a series of two doses given over 2 days via intra-hepatic artery infusion; or (c) one intratumoral injection, in week 1, followed by 5 daily doses of valganciclovir in week 2 in patients enrolled in this study who have been diagnosed with advanced primary or metastatic tumors to the liver.

Phase I

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