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A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

NCT04180215 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-09-15

No results posted yet for this study

Summary

This is a 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.

Conditions

  • HPV-Related Squamous Cell Carcinoma

Interventions

DRUG

HB-201 intravenous administration.

Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).

DRUG

HB-202 intravenous administration alternating with HB-201 intravenous administration.

Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).

DRUG

HB-201 intravenous administration + standard of care regimen including pembrolizumab.

Dose Expansion

DRUG

HB-202 / HB-201 alternating intravenous administration + pembrolizumab.

Dose Expansion

DRUG

HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.

Dose Expansion

DRUG

HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)

Dose escalation; 10 patients

Sponsors & Collaborators

  • Hookipa Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Head of Clinical Development · Hookipa Biotech GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2025-01-09
Completion
2025-01-09
FDA Drug
Yes

Countries

  • United States
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180215 on ClinicalTrials.gov