This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single intratumoral (IT) injection of C5252 in patients with recurrent or progressive glioblastoma (GBM).
This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single IT injection of C5252 in patients with recurrent or progressive GBM. The Part 1 portion of the study is a 3+3 design to evaluate escalating doses of C5252. Total enrollment will depend on the toxicities and/or activity observed, with approximately 36 evaluable participants enrolled. Once the recommended dose (RD) is identified from Part 1, Part 2 Dose Expansion will enroll up to 15 additional participants to further assess the safety, tolerability, and preliminary efficacy of a single IT injection of C5252 monotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Evaluate the safety and tolerability of C5252
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Time frame: Up to 28 days from C5252 injection
Characterize Dose Limiting Toxicities
Incidence of DLTs
Time frame: Up to 28 days from C5252 injection
Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Incidence of DLTs
Time frame: Up to 28 days from C5252 injection
Evaluate the PK of C5252
Measure anti-PD-1 antibody concentration in blood using Anti-PD-1 antibody ELISA test and IL-12 concentration in blood using IL-12p70 ELISA test.
Time frame: Up to 2 years from C5252 injection
Evaluate the viral shedding of C5252
Measure viral shedding of C5252 after intratumoral injection in saliva, nasopharyngeal mucus, and urine using qPCR (quantitative polymerase chain reaction) test.
Time frame: Up to 2 years from C5252 injection
Overall response rate (ORR)
ORR is defined as the proportion of participants who have had a partial response (PR), or complete response (CR) to intervention, based on Investigator Assessment for Neuro-oncology (RANO).
Time frame: Up to 2 years from C5252 injection
Progression-free survival (PFS)
PFS is defined as the time from Day 1 to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RANO.
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Time frame: Up to 2 years from C5252 injection
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: Up to 2 years from C5252 injection