ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer

NCT05182866 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: ASP-1929-103
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer; Squamous Cell Carcinoma of Head and Neck

Keywords

Photoimmunotherapy; HNC; HNSCC; Head and neck; Rakuten Medical; ASP-1929; Fluorescence

Outcome Measures

Primary Outcomes (1)

• Pathologic Tumor Response

  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)

  Day 17 or Day 21

Secondary Outcomes (9)

• Local relapse rate

  12 Months

• Time to local relapse at ASP-1929 PIT-treated site

  12 Months

• Progression-free Survival (PFS)

  12 Months

• Recurrence-free survival (RFS)

  12 Months

• Overall Survival

  24 Months

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Combination Product: ASP-1929 Photoimmunotherapy

Interventions

ASP-1929 Photoimmunotherapy COMBINATION_PRODUCT

ASP-1929 640 mg/m\^2 IV infusion followed approximately 24 hours later by photoimmunotherapy

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 throughout the study and for 60 days after the last dose of ASP-1929
• Provide fresh tumor biopsy at screening. Patients for whom a fresh screening biopsy cannot be obtained may submit an archival sample provided it has been collected within ≤ 3 months of enrollment and no intervening anticancer treatment has occurred within that timeframe or upon agreement from the Sponsor.

You may not qualify if:

• Receiving any other investigational agents or who have received local (including radiotherapy) or systemic treatment for cancer (chemotherapy, immunotherapy, any systemic investigational therapy, or EGFR-directed therapy) within 4 weeks before ASP-1929 PIT treatment.
• History of significant (≥ Grade 3) infusion reaction to anti-EGFR antibodies.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929, or other agents used in study.
• Require use of photosensitizing medications. Note: Photosensitizing medications must be discontinued 30 days before ASP-1929 PIT treatment.
• Tumor invading major blood vessel unless the vessel has been embolized or surgically ligated to prevent hemorrhage; must not have involvement of the common or internal carotid arteries defined as invasion, encasement or direct contact (lack of a radiographically visible plane between the tumor and carotid artery).
• Tumors inappropriate for ASP-1929 PIT treatment, including those in the brain or dura, with perineural involvement at the skull base, CNS disease, or disease in the orbit (if the eye has been previously removed, consult with Medical Monitor before excluding).
• History of distant metastatic disease (M1) based on standard of care imaging.
• Any contraindications for CT or 18FDG PET/CT imaging.
• Weight \> 350 pounds (weight limit for scanner table), or unable to fit within the imaging gantry.
• Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to high-intensity light (eg, eye examinations, surgical procedures) that are unrelated to ASP-1929 PIT treatment, the disease under study, or the study overall.
• Diagnosed and/or treated for additional malignancy within 3 years before study Day 1, except for those with a negligible risk of metastasis or death
• Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome -related illness.
• Known infection or detection of active Hepatitis B (eg, HBsAg positive), Hepatitis C (eg, RNA \[qualitative\]), or SARS-CoV-2 (qualitative).
• Received a live, attenuated vaccine within 4 weeks before Day 1 or anticipation of receiving a live, attenuated vaccine that will be required during the study (based on known medical history).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Rakuten Medical, Inc.: lead
• Shimadzu Corporation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Vassiliki Saloura, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 21, 2022
• Primary Completion: July 11, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)