A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus 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, of Which at Least One Line Must Be Systemic Therapy

Rakuten Medical, Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

阶段: 3 期
状态: 招募中
发起方: Rakuten Medical, Inc.

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•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

排除标准

•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

研究者

发起方

Rakuten Medical, Inc.

相似试验

招募中

4 期

ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head and Neck Cancer for Patients Who Have Failed at Least Two Lines of TherapySquamous Cell Carcinoma of Head and NeckD000077195

JPRN-jRCT2071200060Arron Sarah275

进行中（未招募）

1 期

A global study that is planned to confirm and expand on safety and effectiveness of ASP-1929 vs Physician’s choice standard of care (assigned by chance) for the treatment of patients with recurring head and neck cancer found in tissue near the skin surface, restricted to a localized area and for which patients have failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapyocoregional, recurrent head and neck squamous cell carcinomaMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-002513-36-GRRakuten Medical, Inc.275

进行中（未招募）

1 期

EUCTR2018-002513-36-ESRakuten Aspyrian, Inc.275

进行中（未招募）

1 期

EUCTR2018-002513-36-BERakuten Medical, Inc.275

进行中（未招募）

1 期

A global study that is planned to confirm and expand on safety and effectiveness of ASP-1929 vs Physician’s choice standard of care (assigned by chance) for the treatment of patients with recurring head and neck cancer found in tissue near the skin surface, restricted to a localized area and for which patients have failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapyocoregional, recurrent head and neck squamous cell carcinomaMedDRA version: 20.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-002513-36-DERakuten Aspyrian, Inc.275