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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

January 9, 2025

Study Completion Date

January 9, 2025

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

Trial Locations (34)

1081

Amsterdam UMC, Locatie VUMC, Amsterdam

8041

Hospital de la Santa Creu i Sant Pau, Barcelona

10016

Grossman School of Medicine, New York

10021

Memorial Sloan Kettering Cancer Center, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10461

Montefiore-Einstein Center for Cancer Care, The Bronx

11501

Perlmutter Cancer Center at NYU Langone Hospital-Long Island, New York

22908

University of Virgina Health System, Charlottesville

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

29605

Greenville Hospital System University Medical Center (ITOR), Greenville

33136

Sylvester Comprehensive Cancer Center, Miami

35294

O'Neal Comprehensive Cancer Center at UAB, Birmingham

41013

Hospital Universitario Virgen del Rocio, Seville

44195

Cleveland Clinic, Cleveland

48202

Henry Ford Hospital, Detroit

52242

University of Iowa Hospitals & Clinics, Iowa City

53226

Froedtert Hospital and Medical College of Wisconsin, Milwaukee

60153

Loyola University Medical School, Maywood

60637

University of Chicago Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

66205

University of Kansas Medical Center, Fairway

68114

Nebraska Methodist Hospital, Omaha

72205

University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office, Fayetteville

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

The University of Texas MD Anderson Cancer Center, Houston

85234

Banner MD Anderson Cancer Center, Gilbert

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

90095

UCLA (University of California, Los Angeles), Los Angeles

97213

Providence Portland Medical Center, Portland

410009

Hospital Universitario Virgen Macarena, Seville

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

Hookipa Biotech GmbH

INDUSTRY