Evidence map›Paper›PMID 34401600›Full record

ArticleContemporary clinical trials communications2021

A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients.

Miko Yamada, Dennis M Miller, Melinda Lowe, Casey Rowe, Dominic Wood, H Peter Soyer, Kelly Byrnes-Blake, Julia Parrish-Novak, Laura Ishak, James M Olson and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02097875 (A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
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.

NCT02097875 phase1completednot on this map

A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer

TypeinterventionalSponsorBlaze Bioscience Australia Pty LtdRan2013 to 2015Enrolled21ConditionsSkin NeoplasmsArmsBLZ-100
3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. More Than a Glow: How Cyanine Dyes Shape Tracer Pharmacokinetics.Angewandte Chemie (International ed. in English) · 2026
    Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Tissue-seeking dyes for in vivo applications.Smart molecules : open access · 2024
    Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Intraoperative Tumor Detection Using Pafolacianine.International journal of molecular sciences · 2022
    Review
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

14 authors.

Miko YamadaThe University of Queensland Diamantina Institute, The University of Queensland, Dermatology Research Centre, Brisbane, Queensland, Australia.
Dennis M MillerBlaze Bioscience, Inc., Seattle, WA, USA.
Melinda LoweMedicines Development Limited, Southbank, Victoria, Australia.
Casey RoweVeracity Clinical Research, Brisbane, Queensland, Australia.
Dominic WoodIQ Pathology, Brisbane, Queensland, Australia.
H Peter SoyerThe University of Queensland Diamantina Institute, The University of Queensland, Dermatology Research Centre, Brisbane, Queensland, Australia.
Kelly Byrnes-BlakeNorthwest PK Solutions, LLC, Sultan, WA, USA.
Julia Parrish-NovakBlaze Bioscience, Inc., Seattle, WA, USA.
Laura IshakBlaze Bioscience, Inc., Seattle, WA, USA.
James M OlsonFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Gordon BrandtBrandt Biotech, LLC, Issaquah, WA, USA.
Paul GriffinQ-Pharm Pty Ltd, QIMR Berghofer Medical Research Institute, And Mater Hospital and Mater Research, Queensland, Australia.
Lynda SpelmanVeracity Clinical Research, Brisbane, Queensland, Australia.
Tarl W ProwThe University of Queensland Diamantina Institute, The University of Queensland, Dermatology Research Centre, Brisbane, Queensland, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BLZ-100 (tozuleristide) is an intraoperative fluorescent imaging agent that selectively detects malignant tissue and can be used in real time to guide tumor resection. The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of BLZ-100 and to explore the pharmacodynamics of fluorescence imaging of skin tumors. In this first-in-human study, BLZ-100 was administered intravenously to 21 adult patients 2 days before excising known or suspected skin cancers. Doses were 1, 3, 6, 12, and 18 mg, with 3-6 patients/cohort. Fluorescence imaging was conducted before and up to 48 h after dosing. BLZ-100 was well tolerated. There were no serious adverse events, deaths, or discontinuations due to adverse events, and no maximum tolerated dose (MTD) was identified. Headache (n = 2) and nausea (n = 2) were the only BLZ-100 treatment-related adverse events reported for >1 patient. Median time to maximal serum concentration was <0.5 h. Exposure based on maximal serum concentrations increased in a greater than dose-proportional manner. For intermediate dose-levels (3-12 mg), 4 of 5 basal cell carcinomas and 4 of 4 melanomas were considered positive for BLZ-100 fluorescence. BLZ-100 was well tolerated at all dose levels tested and these results support further clinical testing of this imaging agent in surgical oncology settings. Clinicaltrials.gov: NCT02097875.

Indexed as

CTX, chlorotoxinCystine-knot miniproteinsFluorescent dyesNCI CTCAE, National Cancer Institute's Common Terminology Criteria for Adverse EventsNMSC, non-melanoma skin cancerPK, pharmacokinetic(s)Skin neoplasms

Identifiers

PMID34401600
PMCPMC8355837

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Registered trials

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.