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Trial record 1 of 1 for:    H-200-001
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A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

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ClinicalTrials.gov Identifier: NCT04180215
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Hookipa Biotech GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HPV-Related Squamous Cell Carcinoma Drug: HB-201 intravenous administration. Drug: HB-202 intravenous administration alternating with HB-201 intravenous administration. Drug: HB-201 intravenous administration + standard of care regimen including pembrolizumab. Drug: HB-202 / HB-201 alternating intravenous administration + pembrolizumab. Drug: HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab. Drug: HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C) Phase 1 Phase 2

Detailed Description:

HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV 16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people.

The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: HB-201 intravenous administration.
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
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.
 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).
Experimental: Ph II, Group B
Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.
 Drug: HB-201 intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion
Experimental: Ph II, Group E
Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.
 Drug: HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Dose Expansion
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..
 Drug: HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Dose Expansion
Experimental: Ph I, sub-study
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy
 Drug: HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)
Dose escalation; 10 patients


Outcome Measures
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Primary Outcome Measures :
  1. Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities. [ Time Frame: From dosing until 21-28 days after first dose ]
    Determine the recommended Phase II dose in terms of safety and tolerability for intravenously administered HB-201, and intravenously administered HB-202 by assessing drug limiting toxicities.

  2. Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate. [ Time Frame: Until progression, (estimated up to 30-months) ]
    Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using Response Evaluation Criteria in Solid Tumors (RECIST) to determine objective response rate (ORR).


Secondary Outcome Measures :
  1. Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity). [ Time Frame: From informed consent through 30 days after last dose. ]
    Assess the safety and tolerability of dosage regimens of HB-201 and HB-202 by monitoring the type, frequency, and severity of AEs and SAEs by monitoring the type, frequency, and severity of AEs and SAEs.

  2. Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate. [ Time Frame: Until progression, (estimated up to 30-months) ]
    Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using RECIST and iRECIST

  3. Phase II Dose Expansion: Number of participants with confirmed duration of preliminary antitumor activity. [ Time Frame: Up to 30-months (until progression) ]
    Confirm duration of preliminary antitumor activity of dosage regimens of HB-201 and HB-202 alone of in combination with pembrolizumab, using RECIST and iRECIST

  4. Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity). [ Time Frame: From informed consent through 30 days after last dose ]
    Assess the safety and tolerability of dosage regimens of HB-201 and HB-202 alone or in combination with pembrolizumab by monitoring the type, frequency, and severity of AEs and SAEs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180215


Contacts
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Contact: General Hookipa Contact 1-866-544-8544 hookipa@careboxhealth.com
Contact: Backup Hookipa Contact clinicaltrials@hookipapharma.com

Locations
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Sponsors and Collaborators
Hookipa Biotech GmbH
Investigators
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Study Director: Chief Medical Officer Hookipa Biotech GmbH
More Information
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Responsible Party: Hookipa Biotech GmbH
ClinicalTrials.gov Identifier: NCT04180215    
Other Study ID Numbers: H-200-001
2019-000907-34 ( EudraCT Number )
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hookipa Biotech GmbH:
Vaccine
Gene Therapy
TheraT®
E7E6
HPV 16 E7E6
HNSCC
HPV 16+ head and neck squamous cell cancer
Oropharyngeal cancer
HPV16
 HPV 16
Head and neck cancer
Carcinoma
Carcinoma, squamous cell
Squamous cell carcinoma of head and neck
Neoplasms, squamous cell
Head and neck neoplasms
Pembrolizumab
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action