Status:
ACTIVE_NOT_RECRUITING
ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
Lead Sponsor:
Rakuten Medical, Inc.
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in...
Detailed Description
The study will have an Experimental Arm and a Control Arm. Experimental Arm: Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles within a period of up to 12 mont...
Eligibility Criteria
Inclusion
- Overall
- Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
- Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy
- Have completed prior curative radiation therapy for treatment of their head and neck region
- Have locoregional head and neck tumor site(s) that are all accessible to light illumination
- Have target tumors that are clearly measurable by contrast enhanced CT scan, or MRI scan with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media.
- Have a life expectancy of \> 6 months, based on Investigator judgment
- Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
- Female patients of childbearing potential must not be pregnant or breastfeeding and agree to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion
- Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Overall
Exclusion
- Have a history of significant (\>= Grade 3) cetuximab infusion reactions
- Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from adverse events due to a previously administered agent
- Have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or have not recovered from adverse events due to previously administered agent
- Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered from adverse events, due to previously administered agent or intervention
- Have a present history of distant metastatic disease (M1)
- Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
- Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel
- Have impaired hepatic function
- Have impaired renal function
- Have 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 trial requirements
- Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03769506
Start Date
May 9 2019
End Date
December 1 2025
Last Update
January 16 2025
Active Locations (22)
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1
Cancer Clinic
Miami, Florida, United States, 33176
2
Cancer Clinic
Tampa, Florida, United States, 33606
3
Cancer Clinic
Atlanta, Georgia, United States, 30322
4
Cancer Clinic
Lexington, Kentucky, United States, 40536