Evidence map›Paper›PMID 34165660›Full record

ArticleInternational journal of clinical oncology2021

A phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma.

Makoto Tahara, Susumu Okano, Tomohiro Enokida, Yuri Ueda, Takao Fujisawa, Takeshi Shinozaki, Toshifumi Tomioka, Wataru Okano, Merrill A Biel, Kosuke Ishida and 1 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed
10.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 106 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Internalization-Dependent EGFR-Targeted Photoactivation by Cetuximab-I21 Conjugates.Journal of immunotherapy (Hagerstown, Md. : 1997) · 2026
    Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Preliminary observations on peripheral inflammatory markers in NIR-PIT and ICI-treated recurrent head and neck squamous cell carcinoma.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Article
  12. Article
  13. Article
  14. Advancements in Intraoperative Imaging for Enhanced Surgical Precision.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2026
    Review
  15. Article
  16. Article
  17. Trends in immunotherapy for oral squamous cell carcinoma.Cellular oncology (Dordrecht, Netherlands) · 2025
    Review
  18. Review
  19. Review
  20. Interleukin 15 (IL15)-based near-infrared photoimmunotherapy.Cancer immunology, immunotherapy : CII · 2025
    Article

14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Makoto TaharaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. matahara@east.ncc.go.jp.ORCID http://orcid.org/0000-0001-9035-3106
Susumu OkanoDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Tomohiro EnokidaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Yuri UedaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Takao FujisawaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Takeshi ShinozakiDepartment of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Toshifumi TomiokaDepartment of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Wataru OkanoDepartment of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Merrill A BielClinical Development, Rakuten Medical Inc., 900 Concar Drive, San Mateo, CA, 94402, USA.
Kosuke IshidaClinical Development, Rakuten Medical Japan, K.K., Futako Tamagawa Rise Office, 2-21-1, Tamagawa, Setagaya-ku, Tokyo, Japan.
Ryuichi HayashiDepartment of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
National Cancer Center Hospital East · JPRakuten (Japan) · JPRakuten (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo determine the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of a single cycle of RM-1929 photoimmunotherapy, an anti-EGFR antibody cetuximab conjugated with a light-activatable dye (IRDye

methodsPatients received a single fixed dose (640 mg/m

resultsThree Japanese patients were enrolled who had failed ≥ 3 prior lines of therapy including radiation, chemotherapy, cetuximab, and immunotherapy. Target lesions were: submental lesion; right superficial cervical node lesion and oropharynx lesion; and external auditory canal lesion. All patients experienced ≥ 1 treatment-emergent adverse event (TEAE), but none were considered dose-limiting. TEAEs were mild to moderate in severity except for one grade 3 application-site pain, which was transient, resolved without sequelae within 24 h, and did not affect study treatment administration. Thirteen of 17 TEAEs reported were possibly or probably related to study treatment. Three patient reports of application-site pain and localized edema were deemed probably related to study treatment. Objective response was observed in two patients (both partial responses). The third patient had disease progression. RM-1929 concentrations and pharmacokinetic parameters were similar in all patients. No patients tested positive for anti-drug antibodies.

conclusionsRM-1929 photoimmunotherapy showed a manageable safety profile in rHNSCC. Tumor response in these heavily pre-treated patients was clinically meaningful and warrants further investigation. CLINICAL

trial registrationThe trial was registered with the Japanese registry of clinical trials as jRCT2031200133.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsCetuximabHumansImmunotherapyJapanNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckCetuximabCetuximab-IR700DX conjugateLight-activatable dye (IRDye®700DX)PhotoimmunotherapyRecurrent head and neck squamous cell carcinomaRM-1929 (cetuximab sarotalocan)Tumor-targeted monoclonal antibodies

Identifiers

PMID34165660
PMCPMC8449763
OpenAlexW3175959389

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.