Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04313868
Other study ID # EPB-002
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date June 13, 2014
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source GenVivo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 1, non-randomized, open label dose escalation clinical trial evaluating the safety of GEN2 in participants with primary & metastatic liver tumors.


Description:

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 of GEN2. Phase IA is divided into three routes of administration: (a) Phase 1A.1 which explores peripheral IV infusion; (b) Phase IA.2 which investigates hepatic arterial infusion and (c) Phase IA.3 which examines intratumoral delivery.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 61
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumor(2) in the liver that are refractory to standard therapy or for which no curative standard therapy exists. - Evidence of radiographically measurable or evaluation disease on a baseline PET-CT scan. - 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 < 1. - Patient must be legally considered an adult in the country in which they are participating in the study. - Last dose of antineoplastic therapy, except for hormonal therapy, must be > 21 days. External beam radiotherapy must have been <25% bone marrow-containing skeleton. - Patients may be Hepatitis B and C positive. - 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. Last dose of steroids must be >7 days. - Karnofsky performance status must be > or = 70 - Childs-Pugh Classification Score of 7 or less - Life Expectancy of at least 3 months - Patients must be able to travel to alternate medical center for PET/CT scans, if necessary. - Meet the required baseline laboratory data - 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. - Willing and able to comply with scheduled visits, treatment plan, and laboratory tests. Exclusion Criteria: - Concurrent therapy with anticancer agent including any other investigational agent. - Existing intracranial edema or CVA within 6 months of screening - Pregnant or breast-feeding women. Female patients must agree to use effective contraception, must be surgically sterile or must be post-menopausal. 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 start of the study treatment. - Clinically significant cardiac disease (New York Heart Associate, Class III or IV) - Dementia or altered mental status that would prohibit informed consent. - Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study. - Known side effects to antivirals in the ganciclovir class - Patients who are known to be HIV positive. - Patients must not be taking steroids at the time of screening. Last dose of steroids must be >7 days.

Study Design


Intervention

Drug:
GEN2 (HSV-Thymidine Kinase-m2 and hGM-CSF Genes)
GEN2 is an investigational drug combining cytotoxic and immunotherapy.

Locations

Country Name City State
Philippines Makati Medical Center Makati City
Philippines The Medical City Pasig City
Philippines National Kidney and Transplant Institute Quezon City
Philippines St. Luke's Medical Center Quezon City

Sponsors (1)

Lead Sponsor Collaborator
GenVivo, Inc.

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) The MTD is the defined as the highest dose level at which, at most, one patient experiences a DLT. First 3 weeks of GEN2 Administration
Primary Dose Limiting Toxicity (DLT) Grade 4 neutropenia
Grade 4 thrombocytopenia;
Grade 3 or greater nausea and/or vomiting despite the use of adequate/maximal medical intervention and/or prophylaxis;
Any Grade 3 or greater non-hematological toxicity (except Grade 3 injection site reaction, alopecia, fatigue);
Retreatment delay of more than 3 weeks due to delayed recovery from a toxicity related to treatment with GEN2;
Grade 3 or greater allergic (hypersensitivity) reaction despite the appropriate use of premedications (defined within the CTC as "Prolonged" (e.g., not rapidly reponsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae (e.g., renal impairment, pulmonary infiltrates).
First 3 weeks of GEN2 Administration
Primary Recommended Phase 2 Dose (RP2D) The RP2D will be administered for Phase 1B. It is determined when the accelerated phase ends for Phase IA and the dose assignment for a new patient in the standard dose escalation will follow a modified Fibonacci scheme. If a modified Fibonacci has already been used, the RP2D will be explored from the remaining intervals between the dose which had no DLTs and the Maximum Administered Dose (MAD). First 3 weeks of GEN2 Administration
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Each Adverse Event is to be classified by the Investigator as serious or non-serious. The classification of the gravity of the event determines the reporting procedures to be followed. Treatment Initiation until 30 days after last dose of GEN2
Secondary Plasma pharmacokinetics of GEN2 GEN2 PK Cmax is dose proportional. During Week 1 of Cycle 1, Cycle 2 & Cycle 6 (each cycle is 28 days)
Secondary HSV-TK-m2 protein expression from GEN2 via serial [18F]FHBG PET and/or SPECT imaging Identify number of participants with positive [18F] FHBG scan Day 3-8 of GEN2 Treatment
Secondary Preliminary Evidence of anti-tumor activity of GEN2 Measure of anti-tumor efficacy based on objective tumor assessments made according to the irRECIST 1.1 Week 9 and every 6 weeks thereafter through study completion, an average of 8 months.
Secondary 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 No replication-competent retrovirus. No vector integration into genomic DNA of PBLS. No GM-CSF detectable in patients after GEN2 administration Cycle 1, Cycle 2, Cycle 6, after 6th month on treatment, annually thereafter
See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2