A Study of TheraT® Vector(s) Expressing HPV 16+ in Patients With HPV 16+ Confirmed Cancers
Purpose
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.
Condition
- HPV-Related Squamous Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Ph I, Group 1 |
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph I, Group 2 |
Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph I, Group 3 |
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph I, Group 4 |
Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph II, Group A |
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph II, Group B |
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care and are eligible to receive immune checkpoint inhibitor as part of standard of care. |
|
Experimental Ph II, Group C |
Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph II, Group D |
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. |
|
Experimental Ph II, Group E |
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care and are eligible to receive immune checkpoint inhibitor as part of standard of care. |
|
Experimental Ph II, Group F |
Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. |
|
Recruiting Locations
Bronx, New York 10461
More Details
- Status
- Recruiting
- Sponsor
- Hookipa Biotech GmbH
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.