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HB-200

Phase 1

HPV16+ Squamous Cell Carcinoma | Small molecule | Oncology |HOOKIPA Pharma Inc.|Trials Updated: Jan 20, 2026

HB-200 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

HB-200 clinical trials

HB-200 · 1 trial · 1 indication

Early Phase 1 1
NCT06373380A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)HPV16+ Squamous Cell Carcinoma
ACTIVE NOT_RECRUITING7 Analytics
EARLY_PHASE1ACTIVE NOT_RECRUITING
A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)
HPV16+ Squamous Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluable for overall survival
up to 3 years

Patients who have received at least one dose of treatment will be considered evaluable. Origin time point will be from start of treatment.

Secondary Endpoints

Number of participants with adverse events (type, frequency, severity).
1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HB-200 armEXPERIMENTALHB-202 and HB-201 will be given in an alternating fashion for 4 total treatments.

Interventions

NameTypeDescription
HB-200DRUGHB-200 arm will receive HB-202 and HB-201 (HB-202: 1 x 10 \^7 RCV FFU and HB201: 5 x 106 RCV FFU) in an alternating fashion every (21 days) intravenously for 4 doses (2 doses each of HB-202 and HB-201 alternating).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of HPV16+ squamous cell carcinoma of the head and neck post standard of care definitive therapy. * History of histologically confirmed HPV16+ squamous cell cancer (from in-house or local evaluation by HPV16 R...

Countries:United States
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Frequently asked questions about HB-200

What is HB-200 used for?

HB-200 is being studied for HPV16-positive squamous cell carcinoma, including head and neck squamous cell cancer. It is an investigational therapy in early clinical development and is not approved for any use. The research focuses on patients with HPV16-positive tumors.

Who is developing HB-200?

HB-200 is being developed by HOOKIPA Pharma Inc., which trades on the Nasdaq under the ticker HOOK. The company is running the clinical program for this asset in HPV16-positive squamous cell carcinoma.

What phase is HB-200 in?

HB-200 is in Phase 1 clinical development. The program includes one early Phase 1 trial that is currently active but no longer recruiting participants. It has not completed any trials and is not approved for commercial use.

What clinical trial is HB-200 in?

HB-200 is being evaluated in the trial NCT06373380, titled A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer. The trial is active but not recruiting, enrolled 7 participants, and is being conducted in the United States.

Is HB-200 approved by the FDA?

HB-200 is not approved. It is an investigational therapy still in Phase 1 clinical development, so it is not available outside of clinical trials. The only study of HB-200 is an early Phase 1 trial that is active but not recruiting.

Is HB-200 the same as HB-201 or HB-202?

HB-200 refers to the combination of HB-201 and HB-202, which are studied together in the Phase 1 trial NCT06373380. That trial is titled A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer.