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

NCT03769506 | Active Not Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: ASP-1929-301
• Study Type: interventional
• Target: 135
• Locations: 4 countries
• Sites: 22

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

Conditions

Head and Neck Cancer

Keywords

Rakuten Medical; ASP-1929; PIT; Photoimmunotherapy; HNC; HNSCC; Head and neck; EGFR; Cetuximab; Erbitux; RM-1929

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  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.

  24 months

• Overall Survival (OS)

  OS, defined by the time interval between the patient randomization and death due to any cause.

  24 months

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  24 months

• Duration of Response (DoR)

  24 months

• Event-Free Survival (EFS)

  24 months

• Eastern Cooperative Oncology Group (ECOG) performance status

  24 months

• Quality of Life (QoL) assessment - EORTC QLQ-C30

  24 months

Study Arms (2)

ASP-1929 Photoimmunotherapy

EXPERIMENTAL

Use of ASP-1929 Photoimmunotherapy

Combination Product: ASP-1929 Photoimmunotherapy

Physician's Choice SOC

ACTIVE COMPARATOR

docetaxel, cetuximab, methotrexate, paclitaxel

Drug: Physician's Choice SOC

Interventions

ASP-1929 Photoimmunotherapy COMBINATION_PRODUCT

Use of ASP-1929 PIT therapy

ASP-1929 Photoimmunotherapy

Physician's Choice SOC DRUG

docetaxel, cetuximab, methotrexate, paclitaxel

Physician's Choice SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rakuten Medical, Inc.: lead

Study Sites (22)

Cancer Clinic

Miami, Florida, 33176, United States

Location

Cancer Clinic

Tampa, Florida, 33606, United States

Location

Cancer Clinic

Atlanta, Georgia, 30322, United States

Location

Cancer Clinic

Lexington, Kentucky, 40536, United States

Location

Cancer Clinic 1

Philadelphia, Pennsylvania, 19107, United States

Location

Cancer Clinic 2

Philadelphia, Pennsylvania, 19107, United States

Location

Cancer Clinic

Houston, Texas, 77030, United States

Location

Cancer Clinic

Vadodara, Gujarat, 390011, India

Location

Cancer Clinic

Vadodara, Gujarat, 391760, India

Location

Cancer Clinic

Bangalore, Kamataka, 560099, India

Location

Cancer Clinic

Kochi, Kerala, 682041, India

Location

Cancer Clinic

Chennai, Tamil Nadu, 600036, India

Location

Cancer Clinic

Hyderabad, Telangana, 500034, India

Location

Cancer Clinic

Kolkata, West Bengal, 700160, India

Location

Cancer Clinic

Mumbai, 400012, India

Location

Cancer Clinic

Nagoya, Aichi-ken, 464-8681, Japan

Location

Cancer Clinic

Sapporo, Hokkaido, 060-8648, Japan

Location

Cancer Clinic

Okayama, Okayama-ken, 700-8558, Japan

Location

Cancer Clinic

Chuo-ku, Tokyo, 104-0045, Japan

Location

Cancer Clinic

Taichung, 40705, Taiwan

Location

Cancer Clinic

Taipei, 10048, Taiwan

Location

Cancer Clinic

Taoyuan District, 33305, Taiwan

Location

Related Publications (3)

• Kobayashi H, Furusawa A, Rosenberg A, Choyke PL. Near-infrared photoimmunotherapy of cancer: a new approach that kills cancer cells and enhances anti-cancer host immunity. Int Immunol. 2021 Jan 1;33(1):7-15. doi: 10.1093/intimm/dxaa037.

  PMID: 32496557 BACKGROUND

• Kobayashi H, Choyke PL. Near-Infrared Photoimmunotherapy of Cancer. Acc Chem Res. 2019 Aug 20;52(8):2332-2339. doi: 10.1021/acs.accounts.9b00273. Epub 2019 Jul 23.

  PMID: 31335117 BACKGROUND

• Magagoum SH, Biteghe FAN, Siwe GT, Lang D, Lekena N, Barth S. SNAP-Tag-Based Recombinant Photoimmunotherapeutic Agents for the Selective Detection and Killing of Light-Accessible Melanotransferrin-Expressing Melanoma and Triple-Negative Breast Cancer. Cancer Med. 2025 May;14(9):e70912. doi: 10.1002/cam4.70912.

  PMID: 40326388 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ethan Chen, MD

  Rakuten Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: May 9, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); IN (8); JP (4); TW (3)