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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

Description

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.


Detailed Description
HB-201 and HB-202 are 'vectors', modified viruses intended to train the body to recognize antigens found in HPV 16+ cancer. Phase I Dose Escalation will comprise two treatment groups evaluating HB-201 single vector therapy (Groups 1 and 2) and two treatment groups evaluating HB-201 & HB-202 two-vector therapy (Groups 3 and 4). Group 1 and Group 2 Phase I Dose Escalation will determine a safe recommended Phase II dose of HB-201 for intravenous (IV) and intratumoral treatment. Group 3 and Group 4 Phase I Dose Escalation will determine a safe RP2D of HB-202 for IV treatment. Various doses of the investigational therapies (HB-201 and HB-202) and dosing schedules may be evaluated in separate groups of patients (cohorts) during Phase I Dose Escalation. Phase II Dose Expansion may have up to six treatment groups (Groups A to F) with HB-201 and HB-202 administered at the recommended Phase II doses and the dosing schedule determined during Phase I Dose Escalation. Potential groups will explore the following treatments: HB-201 single vector therapy; HB-201 & HB-202 two-vector therapy; HB-201 single vector therapy in combination with an immune checkpoint inhibitor; and/or HB-201 & HB-202 two-vector in combination with an immune checkpoint inhibitor.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria All Patients:
  • Documentation of confirmed HPV 16+ cancer via genotype testing.
  • ≥ 1 measurable lesion by imaging for tumor response following RECIST
  • ECOG performance status of 0 to 1.
  • Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
  • Screening laboratory values must meet protocol-specified criteria. Treatment Group 1, Group 3, Group A, or Group D:
  • Documentation of confirmed head and neck squamous cell carcinoma.
  • Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy.
  • Able to provide tumor tissue following last treatment, unless otherwise agreed. Treatment Group 2, Group 4, Group C, or Group F:
  • Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy.
  • Safe and accessible tumor site amenable for biopsy and intratumoral administration.
  • Apart from the tumor site(s) amenable for biopsy and IT administration, ≥ 1 measurable lesion for RECIST assessment. Treatment Group B or Group E:
  • Documentation of confirmed head and neck squamous cell carcinoma.
  • Eligible, per standard of care, to receive immune checkpoint inhibitor.
  • Able to provide tumor tissue following last treatment, unless otherwise agreed. Exclusion Criteria: All patients:
  • Untreated and/or symptomatic metastatic central nervous system disease, unless protocol-defined criteria is met.
  • Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
  • Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria is met.
  • Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
  • Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met.
  • Not meeting the protocol-specified washout periods for prohibited medications.
  • Prior anaphylactic or other severe reaction to human immunoglobulin or antibody formulation administration.
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
  • Known history of acquired immunodeficiency syndrome. For patients in Groups B or E • History of severe hypersensitivity reaction to or other contraindication to receiving immune checkpoint inhibitor.

Sites

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