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A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients With HPV 16+ Confirmed Cancers

  • Protocol Number: 201909006
  • Principal Investigator: Adkins, Douglas
  • Cancer Types: Head & Neck

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
info@ccadmin.wustl.edu

Brief Summary

This is an 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.

Protocol Interventions

HB-201 intravenous administration., HB-201 intratumoral administration for first dose, followed by HB-201 intravenous administration for subsequent doses., HB-202 intravenous administration alternating with HB-201 intravenous administration., HB-201 intratumoral administration for first dose; followed by HB-202 intravenous administration alternating with HB-201 intravenous administration for subsequent doses., Immune checkpoint inhibitor regimen per standard of care + HB-201 intravenous administration., HB-201 intravenous administration + standard of care regimen including pembrolizumab., HB-201 intratumoral administration for first dose followed by HB-201 intravenous administration for subsequent doses at recommended phase II dose and determined schedule., Immune checkpoint inhibitor regimen per standard of care + HB-202/HB-201 alternating intravenous administration., HB-201 intratumoral administration for first dose; followed by HB-202 intravenous administration alternating with HB-201 intravenous administration for subsequent doses at recommended phase II dose., HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab., HB-201 intravenous administration for a limited number of dose administration., HB-202 intravenous administration alternating with HB-201 intravenous administration for a limited number of dose administration, HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)