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HB-200

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

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 Carcinoma
NCT063733807
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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 an investigational small molecule being developed for the treatment of HPV16+ squamous cell carcinoma, a type of cancer associated with human papillomavirus type 16 infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing HB-200?

HB-200 is being developed by HOOKIPA Pharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol HOOK. The company is conducting clinical trials to evaluate the safety and efficacy of HB-200 in patients with HPV16+ squamous cell carcinoma.

What phase is HB-200 in?

HB-200 is currently in Phase 1 clinical development. It is being studied in an early Phase 1 clinical trial that is active but not recruiting participants. The drug is investigational and has not yet received approval from regulatory agencies for commercial use.

What clinical trials is HB-200 in?

HB-200 is being evaluated in a clinical trial with the identifier NCT06373380. This trial is studying HB-202/HB-201 in people with HPV16-positive head and neck squamous cell cancer. The trial is in early Phase 1, is active but not recruiting, and has an enrollment of 7 participants in the United States.

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

HB-200 is not the same as HB-202 or HB-201. The clinical trial NCT06373380 is studying a combination of HB-202 and HB-201, which are separate investigational agents. HB-200 is a distinct drug candidate being developed by HOOKIPA Pharma Inc. for the same indication of HPV16+ squamous cell carcinoma.