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

Phase 3

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Combination Product: ASP-1929 Photoimmunotherapy; Drug: Physician's Choice SOC

• Registration Number: NCT03769506
• Lead Sponsor: Rakuten Medical, Inc.

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 Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy

Detailed Description

The study will have an Experimental Arm and a Control Arm.

Experimental Arm:
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2019-05-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 275

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.
• Failed or progressed following prior platinum 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 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

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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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP-1929 Photoimmunotherapy	ASP-1929 Photoimmunotherapy	Use of ASP-1929 Photoimmunotherapy
Physician's Choice SOC	Physician's Choice SOC	docetaxel, cetuximab, methotrexate, paclitaxel

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	24 months	PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the Central Radiographic Review according to RECIST 1.1 with modifications, or death from any cause, whichever occurs first.
Overall Survival (OS)	24 months	OS, defined by the time interval between the patient randomization and death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	24 months	ORR, defined by the percentage of patients with the best overall response of complete response (CR) or partial response (PR) by RECIST 1.1 with modifications.
Duration of Response (DoR)	24 months	DoR, defined as the time from first objective response (CR or PR) to the date of the first documented tumor progression, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications or date of death due to any cause, whichever occurs first.
Event-Free Survival (EFS)	24 months	EFS, defined as the time interval from randomization to a \>20% increase in tumor size from baseline (CT or MRI scan at screening) by Central Radiographic Review according to RECIST 1.1 with modifications, development of new locoregional disease, distant metastatic disease, or death, whichever occurs first.
Eastern Cooperative Oncology Group (ECOG) performance status	24 months
Quality of Life (QoL) assessment - EORTC QLQ-C30	24 months	Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire developed to assess QoL of head and neck cancer participants and consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue...
Quality of Life (QoL) assessment - EORTC QLQ H&N 35	24 months	Change from baseline in EORTC head and neck specific module (EORTC QLQ H\&N 35). EORTC QLQ-H\&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multiple-item scales that assess the symptom of pain, swallowing, senses (taste/smell), speech, social eating, social contact and sexuality. Also, six singl...
Quality of Life (QoL) assessment - EQ 5D-5L	24 months	Change from baseline in EuroQol 5-Dimension 5-Level (EQ 5D-5L) Questionnaire. EQ-5D-5L is a 5-dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) questionnaire developed to assess the patient-generated health state index score from the societal perspective and subjective perceived health. For each dimension, levels of perce...
Population Pharmacokinetics (PK) of ASP-1929	12 months	Estimate covariate effects of ASP-1929 PK through compartmental PK modeling.
Presence of Anti-Drug Antibodies (ADA) of ASP-1929	24 months
Complete Response (CR)	24 months	CR, defined as the proportion of patients with tumor response of CR, as determined by Central Radiographic Review according to RECIST 1.1 with modifications.
Complete Response by Biopsy (CRb)	24 months	CR by histopathologic biopsy of target tumor(s) and a repeated confirmatory histopathologic CR biopsy at least 3 months after initial CR histopathologic biopsy of the target tumor(s) for patients who demonstrate a clinical CR but not an image CR per RECIST 1.1 with modifications, as determined by the Investigator.

Trial Locations

Locations (3)

Cancer Clinic; 🇨🇳 Taoyuan, Taiwan

Cancer Clinic 1; 🇺🇸 Philadelphia, Pennsylvania, United States

Cancer Clinic 2; 🇺🇸 Philadelphia, Pennsylvania, United States