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HB-201 and HB-202 in HPV 16+ Cancers
NCT04180215Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2019
- Primary completion
- Jan 2025
- Countries
- 3
- Sponsor
- HOOKIPA Pharma
- Modality
- Oncolytic Viruses, Vaccines & Immunotherapeutics
- Drugs
- HB-202
- Conditions
- Human Papillomavirus Positive Head And Neck Squamous Cell CarcinomaHPV-positive cancer
01
Overview
Phase 2, open-label trial of HB-202 in Human Papillomavirus Positive Head And Neck Squamous Cell Carcinoma and HPV-positive cancer (6 arms), sponsored by HOOKIPA Pharma. Primary endpoints: Phase II Dose Determination and Objective Response Rate up to 30 months. Started Dec 2019; status: completed.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
Ph I, Group 1/2
HB-201 Monotherapy (Dose Escalation)
Ph I, Group 3/4
HB-202 / HB-201 Alternating (Dose Escalation)
Ph II, Group B
HB-201 + Pembrolizumab
Ph II, Group E
HB-202 / HB-201 + Pembrolizumab (1L)
Ph II, Group F
HB-202 / HB-201 + Pembrolizumab (2L+)
Ph I, sub-study
Imaging Sub-study
03
Who it enrols
Patients with confirmed HPV 16+ cancer (HNSCC or other) with measurable disease, ECOG 0-1, and specific prior treatment requirements depending on the group.
04
Endpoints
Primary
Phase II Dose Determination
Objective Response Rate
Secondary
Adverse Events
Disease Control Rate
Duration of Response
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