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Trial record 1 of 1 for:    toragen
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Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05826275
Recruitment Status : Not yet recruiting
First Posted : April 24, 2023
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Toragen, Inc.

Study Description
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Brief Summary:
This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.

Condition or disease Intervention/treatment Phase
HPV Associated Cancers Drug: TGN-S11 Drug: Pembrolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase I, dose escalation/dose expansion study. Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
To determine the MTD in patients with HPV-associated cancers
 Drug: TGN-S11
Small Molecule
Experimental: Dose Expansion
Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
 Drug: TGN-S11
Small Molecule

Drug: Pembrolizumab
PD-1 checkpoint blockade
Other Name: Keytruda


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 12 months ]
    To determine the maximum tolerated dose (MTD) of TGN-S11 in patients with human papillomavirus (HPV)-associated relapsed, resistant, or metastatic cancer.


Secondary Outcome Measures :
  1. PK Parameters to determine the single dose [ Time Frame: 30 days ]
    Cmax

  2. Steady state pharmacokinetics (PK) of TGN-S11 [ Time Frame: 30 days ]
    AUC


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:

  • Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic
  • Life expectancy of at least 3 months
  • Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies

Exclusion Criteria:

  • Active CNS metastases
  • Have any history of seizure disorder or are taking prophylactic seizure medication
  • Have an active viral, bacterial, or fungal infection
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): NCT05826275


Contacts
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Contact: Claudia Ramos 858-529-7393 ext 1007 study-TGN-011@toragen.com
Contact: Neil J Clendennin, MD, PhD 8585297393 ext 1003 nclendennin@toragen.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10128
Contact: Omayra Sanchez       Omayra.Sanchez@mssm.edu   
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Melissa Shorter       mkshorter@mdanderson.org   
Sponsors and Collaborators
Toragen, Inc.
Investigators
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Study Director: Neil J Clendennin, MD, PhD Chief Medical Officer
More Information
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Additional Information:

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Responsible Party: Toragen, Inc.
ClinicalTrials.gov Identifier: NCT05826275    
Other Study ID Numbers: TGN-S11
First Posted: April 24, 2023    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action