ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer
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ClinicalTrials.gov Identifier: NCT05182866 |
Recruitment Status :
Recruiting
First Posted : January 10, 2022
Last Update Posted : May 2, 2024
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Sponsor:
Rakuten Medical, Inc.
Collaborators:
Shimadzu Corporation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rakuten Medical, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | December 20, 2021 | ||||
First Posted Date ICMJE | January 10, 2022 | ||||
Last Update Posted Date | May 2, 2024 | ||||
Actual Study Start Date ICMJE | January 21, 2022 | ||||
Estimated Primary Completion Date | March 25, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pathologic Tumor Response [ Time Frame: Day 17 or Day 21 ] Proportion of patients with pathologic tumor response-2 (pTR-2) of ASP-1929 PIT-treated lesions. A patient is a pTR-2 responder if overall pTR of ASP-1929 PIT-treated tumors (including primary tumor and lymph node) is greater than or equal to 50% (pTR-2)
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Original Primary Outcome Measures ICMJE |
Pathologic Tumor Response [ Time Frame: 24 Month ] A patient is a pTR-2 responder if all tumors (including primary tumor and lymph node) from which samples are collected are considered as pTR-2.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer | ||||
Official Title ICMJE | Phase 2, Open-label, Single-arm, Window of Opportunity Study of ASP-1929 Photoimmunotherapy With Fluorescence Imaging in Patients With Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma | ||||
Brief Summary | A Phase 2, Open-label, Single-arm, Window of opportunity Study of ASP-1929 Photoimmunotherapy with Fluorescence Imaging in Patients with Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma | ||||
Detailed Description | All patients will receive a combination of ASP-1929 and Photoimmunotherapy (PIT). During illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged at a wavelength in the vicinity of 830 nm with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery approximately 21 days after ASP-1929 PIT treatment. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Combination Product: ASP-1929 Photoimmunotherapy
ASP-1929 640 mg/m^2 IV infusion followed approximately 24 hours later by photoimmunotherapy
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Study Arms ICMJE | Experimental: Single Arm
ASP-1929 640 mg/m^2 treatment by intravenous (IV) infusion followed approximately 24 hours later by illumination (also termed as photoimmunotherapy [PIT]) of tumor(s) using the PIT690 Laser System with a 690 nm light dose of 50 J/cm^2 for superficial illumination and 100 J/cm of diffuser length for interstitial illumination. During the illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery with or without chemotherapy or radiation approximately 21 days after ASP-1929 PIT treatment.
Intervention: Combination Product: ASP-1929 Photoimmunotherapy
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
22 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 31, 2027 | ||||
Estimated Primary Completion Date | March 25, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Note: For patients with HNSCC, tumor locations must be in the oropharynx, oral cavity, sinonasal tract, hypopharynx, or larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05182866 | ||||
Other Study ID Numbers ICMJE | ASP-1929-103 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Rakuten Medical, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Rakuten Medical, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Rakuten Medical, Inc. | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |