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 Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy
Recruiting
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Physician's Choice SOC | Physician's Choice SOC |
The study will have an Experimental Arm and a Control Arm.
Experimental Arm:
Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months
after randomization until the patient has complete remission, progressive disease that is no
longer amendable to study treatment, patient experiences intolerable side effects, or patient
discontinues study treatment.
Control Arm:
Patients may be treated with physician's choice SOC until the patient has progressive
disease, patient experiences intolerable side effects, or patient discontinues study
treatment.
| Name | Type | Description | Interventions |
|---|---|---|---|
| ASP-1929 Photoimmunotherapy | Active Comparator | Use of ASP1929 PIT therapy | |
| Physician's Choice SOC | Active Comparator | docetaxel, cetuximab, methotrexate, paclitaxel |
|
Overall Inclusion Criteria:
- 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 illumination
- Have target tumors that are clearly measurable by contract enhanced CT scan
- 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
agrees 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 Criteria:
- 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 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Progression-Free Survival |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | Time to progression of disease |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Rakuten Medical, Inc. |
April 1, 2021
