A Study of TheraT® Vector(s) Expressing HPV 16+ in Patients With HPV 16+ Confirmed Cancers

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hookipa Biotech; Hookipa Biotech GmbH
• Treatments: Immune Checkpoint Inhibitors

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.

• Able to provide tumor tissue following last treatment, unless otherwise agreed.

Treatment Group 1, Group 3, Group 5, Group 6, 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.

Treatment Group 2, Group 4, Group C, or Group F:

• Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy.

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.

Anal Cancer Cohort:

• Documentation of confirmed HPV 16+ locally advanced or metastatic SCC of anal canal.

• Tumor progression or recurrence on standard of care therapy, including ≥1 systemic therapy.

Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):

• Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.

• At least 1 non-irradiated measurable lesion documented through imaging.

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 and certain backfill cohorts:

• History of severe hypersensitivity reaction to or other contraindication to receiving immune checkpoint inhibitor.

• Allogenic tissue/solid organ transplant.

• History of/Presently having non-infectious pneumonitis requiring treatment.

Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):

• Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.

• Meeting requirements of exclusion criteria for Treatment Group 1 or Group 3