Official Title
A Phase 1 Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GEN2 in Refractory Patients With Primary Hepatocellular Carcinoma or Tumors Metastatic to the Liver
Brief Title
GEN2 Directed Cancer Immunotherapy Trial
Protocol ID
NCT04313868
Lead Sponsor
GenVivo, Inc.
Brief Summary
Phase 1, non-randomized, open label dose escalation clinical trial evaluating the safety
of GEN2 in participants with primary & metastatic liver tumors.
Detailed 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.
Study Period
-
Enrollment Count
61 participants
Eligibility Criteria
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.
Filters
Hepatocellular Carcinoma
Metastatic Cancer
PHASE1
COMPLETED
ADULT
OLDER_ADULT