Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04180215




Registration number
NCT04180215
Ethics application status
Date submitted
20/09/2019
Date registered
27/11/2019

Titles & IDs
Public title
A Phase 1/2 Study in Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
Scientific title
A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers
Secondary ID [1] 0 0
2019-000907-34
Secondary ID [2] 0 0
H-200-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV-Related Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HB-201 intravenous administration.
Treatment: Drugs - HB-202 intravenous administration alternating with HB-201 intravenous administration.
Treatment: Drugs - HB-201 intravenous administration + standard of care regimen including pembrolizumab.
Treatment: Drugs - HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Treatment: Drugs - HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Treatment: Drugs - HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)

Experimental: Ph I, Group 1 and Group 2 - Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.

Experimental: Ph I, Group 3 and Group 4 - Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.

Experimental: Ph II, Group B - Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.

Experimental: Ph II, Group E - Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.

Experimental: Ph II, Group F - Patients with HPV 16+ cancers who had tumor progression or recurrence on standard of care therapy and who are eligible to receive pembrolizumab as part of 2L+ standard of care..

Experimental: Ph I, sub-study - Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy


Treatment: Drugs: HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).

Treatment: Drugs: HB-202 intravenous administration alternating with HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).

Treatment: Drugs: HB-201 intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion

Treatment: Drugs: HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Dose Expansion

Treatment: Drugs: HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion

Treatment: Drugs: HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)
Dose escalation; 10 patients
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.
Timepoint [1] 0 0
From dosing until 21-28 days after first dose
Primary outcome [2] 0 0
Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.
Timepoint [2] 0 0
Until progression, (estimated up to 30-months)
Secondary outcome [1] 0 0
Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).
Timepoint [1] 0 0
From informed consent through 30 days after last dose.
Secondary outcome [2] 0 0
Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.
Timepoint [2] 0 0
Until progression, (estimated up to 30-months)
Secondary outcome [3] 0 0
Phase II Dose Expansion: Number of participants with confirmed duration of preliminary antitumor activity.
Timepoint [3] 0 0
Up to 30-months (until progression)
Secondary outcome [4] 0 0
Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).
Timepoint [4] 0 0
From informed consent through 30 days after last dose

Eligibility
Key inclusion criteria
Inclusion Criteria

All Patients:

* Documentation of confirmed HPV 16+ cancer via genotype testing.
* = 1 measurable lesion by imaging for tumor response following RECIST
* ECOG performance status of 0 to 1.
* Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
* Screening laboratory values must meet protocol-specified criteria.
* Able to provide tumor tissue following last treatment, unless otherwise agreed.

Treatment Group E or Group F:

* Documentation of confirmed head and neck squamous cell carcinoma.
* Eligible to receive pembrolizumab, per standard of care and product label.
* Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.
* Group F: Tumor progression or recurrence on standard of care therapy, including =1 systemic therapy.

Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):

* Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
* At least 1 non-irradiated measurable lesion documented through imaging.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients:

* Metastatic central nervous system disease, and/or carcinomatous meningitis.
* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
* Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria are met.
* Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
* Has a life expectancy of less than 3 months.
* Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met.
* Not meeting the protocol-specified washout periods for prohibited medications.
* Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
* Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
* Known history of acquired immunodeficiency syndrome.

For patients in Groups E or F and certain backfill cohorts:

* History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab.
* History of/Presently having non-infectious pneumonitis requiring treatment.
* Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors.

Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):

* Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.
* Meeting requirements of exclusion criteria for Treatment Group 3

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amsterdam
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hookipa Biotech GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Head of Clinical Development
Address 0 0
Hookipa Biotech GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
General Hookipa Contact
Address 0 0
Country 0 0
Phone 0 0
1-866-544-8544
Fax 0 0
Email 0 0
hookipa@careboxhealth.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04180215