GOAT; Phase I Single-Center Open Label Dose Escalation Study of CGTG-102, a GM-CSF Encoding Oncolytic Adenovirus, for Therapy of Advanced Cancers
Pre-treatment visit - subject will undergo a physical examination with vital signs, a blood
sample will be taken and a PET (Positron emission tomography)-CT (Computer tomography) scan
will be performed.
Thereafter, there will be 4 visits with injections performed on trial days 1, 4, 8 and 15.
The injections are given directly into the tumors with help from using an ultrasound. The
total dose of oncolytic virus the subject will receive will be divided into 1-10 injections
which will be injected into individual tumors in the body. The maximum number of tumors that
can be injected for one treatment will be 10 tumors.
STUDY VISIT 1:
On the day 1 visit, blood samples will be taken as well as two biopsies from one of the
tumors. In addition pleural fluids (fluids from the chest) or ascites (fluids from abdominal
walls) may be collected if possible. Then the subject will receive the first set of
injections with CGTG-102. Before the injections, the subject may be given a dose of Tylenol.
STUDY VISIT 2:
On the day 4 visit, in addition to blood samples being taken the subject will receive a
second round of intratumoral injections into the same tumors selected for injections on day
1. Urine will also be collected right before the subject goes home.
STUDY VISIT 3:
The day 8 visit is identical to the day 4 visit. The same blood samples and urine sample are
STUDY VISIT 4:
On the day 15 visit blood samples and a urine sample will be taken as well as a biopsy from
one of the tumors.
Subjects will have to stay overnight at the hospital after each treatment.
A follow-up visit will be scheduled on days 29 where only blood samples and a urine sample
will be taken.
The end of trial visit is scheduled around day 43 where in addition to lab samples a PET-CT
scan will be performed.
Following day 43 the subject will be contacted by study staff at 6 week intervals for 3
months, then at 3 month intervals for up to one year and yearly thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of CGTC-102 in patients with solid tumors
To assess the safety of the maximum tolerated dose and/or maximum feasible dose of CGTG-102 administered by intratumoral injection in a patient population with unresectable, refractory solid tumors
Martha M Pritchett, MD
Baylor College of Medicine
United States: Food and Drug Administration
|The Methodist Hospital||Houston, Texas 77030|
|Harris County Hospital District Ben Taub||Houston, Texas 77030|