ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

Phase 3

Registration Number: CTRI/2023/05/052728

Lead Sponsor: Rakuten Medical, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 for treatment of their primary or recurrent head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended

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 contrast 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

Exclusion Criteria

Have a history of significant (greater than or equal to 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 (ie, less than or equal to Grade 1 or at baseline) 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 (ie, less than or equal to Grade 1 or at baseline) 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 (ie, less than or equal to Grade 1 or at baseline) 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

With a hemoglobin < 9.0 g/dL, WBC < 2000/µL, and platelets < 100 x 1000/µL

Have impaired hepatic function defined as alkaline phosphatase (hepatic; alkaline phosphatase [ALP]) > 2 times upper limit of normal, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal, or total serum bilirubin > 2 mg/dL (patients with Gilbert’s disease will be excluded if they have a bilirubin greater than or equal to 5 mg/dL)

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

Require examinations or treatments within 4 weeks after ASP-1929 administration where they would be exposed to significant light (eg, eye examinations, elective surgical procedures) unrelated to the study treatment

Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS), defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST 1.1, or death from any cause, whichever one occurs first <br/ ><br>Overall Survival (OS), defined by the time interval between the patient randomization and death due to any cause.Timepoint: 24 months

Secondary Outcome Measures