This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 \& HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.
HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV 16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people. The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
Dose Expansion
Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.
Determine the recommended Phase II dose in terms of safety and tolerability for intravenously administered HB-201, and intravenously administered HB-202 by assessing drug limiting toxicities.
Time frame: From dosing until 21-28 days after first dose
Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.
Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using Response Evaluation Criteria in Solid Tumors (RECIST) to determine objective response rate (ORR).
Time frame: Until progression, (estimated up to 30-months)
Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).
Assess the safety and tolerability of dosage regimens of HB-201 and HB-202 by monitoring the type, frequency, and severity of AEs and SAEs by monitoring the type, frequency, and severity of AEs and SAEs.
Time frame: From informed consent through 30 days after last dose.
Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.
Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using RECIST and iRECIST
Time frame: Until progression, (estimated up to 30-months)
Phase II Dose Expansion: Number of participants with confirmed duration of preliminary antitumor activity.
Confirm duration of preliminary antitumor activity of dosage regimens of HB-201 and HB-202 alone of in combination with pembrolizumab, using RECIST and iRECIST
Time frame: Up to 30-months (until progression)
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Dose Expansion
Dose escalation; 10 patients
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office
Fayetteville, Arkansas, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA (University of California, Los Angeles)
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical School
Maywood, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Fairway, Kansas, United States
...and 24 more locations
Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).
Assess the safety and tolerability of dosage regimens of HB-201 and HB-202 alone or in combination with pembrolizumab by monitoring the type, frequency, and severity of AEs and SAEs.
Time frame: From informed consent through 30 days after last dose