ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer (NCT05182866) | Clinical Trial Compass
Active — Not RecruitingPhase 2
ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer
United States9 participantsStarted 2022-01-21
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent.
* Male or female ≥ 18 years of age at the time of informed consent
* Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC.
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).
* At least one tumor lesion accessible for ASP-1929 PIT illumination that is also amenable to imaging with the Fluorescence Imaging System camera (must be within 0.5 cm and no more than 3 cm depth to the skin or mucosal surface, with the longest diameter less than 5 cm as judged by pre-treatment imaging or examination) and radiographically measurable by RECIST 1.1, as assessed by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of screening.
* Adequate organ function laboratory values (all screening labs should be performed ≤ 14 days of Day 1)
* Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test \[urine or serum\] at screening), not breastfeeding and must be willing to use a method of highly effective birth control, or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929.
* Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence thro…