NCT05265013

ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Recurrent Head and Neck Cancer, With or Without Metastases

Terminated Phase 2 Last updated 4 November 2024

What this trial tests

Phase 2 trial testing ASP-1929 Photoimmunotherapy in Head and Neck Cancer in 16 participants. Terminated before completion.

Timeline

19 April 2022

Primary endpoint
20 November 2023

29 March 2024

Quick facts

Lead sponsor	Rakuten Medical, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	19 April 2022
Primary completion	20 November 2023
Estimated completion	29 March 2024
Sites	5 locations across Taiwan

Drugs / interventions tested

• ASP-1929 Photoimmunotherapy
• pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Rakuten Medical, Inc. — full company profile →

Who can join

20 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.
   Wei Q, Li P, Yang T, Zhu J, et al · · 2024 · cited 102× · PMID 38178200 · DOI 10.1186/s13045-023-01509-2
2. Combination of phototherapy with immune checkpoint blockade: Theory and practice in cancer.
   Zhao Y, Liu X, Liu X, Yu J, et al · · 2022 · cited 48× · PMID 36119019 · DOI 10.3389/fimmu.2022.955920
3. Trial watch: an update of clinical advances in photodynamic therapy and its immunoadjuvant properties for cancer treatment.
   Penetra M, Arnaut LG, Gomes-da-Silva LC. · · 2023 · cited 36× · PMID 37346450 · DOI 10.1080/2162402x.2023.2226535
4. Drug conjugates for the treatment of lung cancer: from drug discovery to clinical practice.
   Zhou L, Lu Y, Liu W, Wang S, et al · · 2024 · cited 27× · PMID 38429828 · DOI 10.1186/s40164-024-00493-8
5. Review of RM-1929 Near-Infrared Photoimmunotherapy Clinical Efficacy for Unresectable and/or Recurrent Head and Neck Squamous Cell Carcinoma.
   Miyazaki NL, Furusawa A, Choyke PL, Kobayashi H. · · 2023 · cited 24× · PMID 37958293 · DOI 10.3390/cancers15215117
6. Dying of Stress: Chemotherapy, Radiotherapy, and Small-Molecule Inhibitors in Immunogenic Cell Death and Immunogenic Modulation.
   Fabian KP, Kowalczyk JT, Reynolds ST, Hodge JW. · · 2022 · cited 18× · PMID 36497086 · DOI 10.3390/cells11233826
7. A new silicon phthalocyanine dye induces pyroptosis in prostate cancer cells during photoimmunotherapy.
   Wolf I, Storz J, Schultze-Seemann S, Esser PR, et al · · 2024 · cited 8× · PMID 39246837 · DOI 10.1016/j.bioactmat.2024.07.025
8. Trends in immunotherapy for oral squamous cell carcinoma.
   Xue N, Wang Y, Wang Z, Zeng X, et al · · 2025 · cited 7× · PMID 40549116 · DOI 10.1007/s13402-025-01068-3