Phase 1 dose escalation and expansion safety study of BLZ-100 in pediatric subjects with primary central nervous system tumors.

Miller, Dennis M.; Lee, Amy; Ojemann, Jeff; Cole, Bonnie; Poliachik, Sandra L.; Ishak, Laura; Hansen, Stacey; Novak, Julie; Leary, Sarah

doi:10.1200/jco.2016.34.15_suppl.tps10584

Cited by 2 publications

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“…Dose-escalation studies revealed that BLZ-100 was well tolerated and has potential to aid in resection of tumours in adult and in paediatric populations. BLZ-100 had lower autofluorescence and better tissue penetration compared to conventional fluorophore precursors such as 5-ALA [87,88]. A recent study evaluated Ac-Lys 0 (800CW)Tyr 3 -ocreotate (800CW-TATE) (Table 1), targeting somatostatin receptor subtype 2 (SSTR 2 ), as a potential tracer in fluorescenceguided surgery of meningiomas.…”

Section: Neuro-oncologymentioning

confidence: 99%

Targeted optical fluorescence imaging: a meta-narrative review and future perspectives

Schouw

Huisman

Janssen

et al. 2021

Eur J Nucl Med Mol Imaging

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Purpose The aim of this review is to give an overview of the current status of targeted optical fluorescence imaging in the field of oncology, cardiovascular, infectious and inflammatory diseases to further promote clinical translation. Methods A meta-narrative approach was taken to systematically describe the relevant literature. Consecutively, each field was assigned a developmental stage regarding the clinical implementation of optical fluorescence imaging. Results Optical fluorescence imaging is leaning towards clinical implementation in gastrointestinal and head and neck cancers, closely followed by pulmonary, neuro, breast and gynaecological oncology. In cardiovascular and infectious disease, optical imaging is in a less advanced/proof of concept stage. Conclusion Targeted optical fluorescence imaging is rapidly evolving and expanding into the clinic, especially in the field of oncology. However, the imaging modality still has to overcome some major challenges before it can be part of the standard of care in the clinic, such as the provision of pivotal trial data. Intensive multidisciplinary (pre-)clinical joined forces are essential to overcome the delivery of such compelling phase III registration trial data and subsequent regulatory approval and reimbursement hurdles to advance clinical implementation of targeted optical fluorescence imaging as part of standard practice.

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Section: Neuro-oncologymentioning

confidence: 99%

Targeted optical fluorescence imaging: a meta-narrative review and future perspectives

Schouw

Huisman

Janssen

et al. 2021

Eur J Nucl Med Mol Imaging

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“…On ex vivo analysis, the sensitivity of the tracer was 82% (>95% if specimens from negative cases were excluded) and specificity was 89%. 34 Based on these encouraging results, a randomized blinded study (BB-006) evaluating fluorescence detection of BLZ-100 was initiated. The accrual goal is 114 patients, and enrollment is currently underway.…”

Section: Tumorpaint-imaging Pediatric Brain Tumorsmentioning

confidence: 99%

“…Approximately 60% to 70% of soft-tissue sarcomas overexpress EGFR. Preclinical studies demonstrated that ABY-029 dosing 4 to 8 h before tumor dissection optimizes tumor-to-background contrast 34 and facilitates same-day tracer dosing, a favorable development compared with conventional EGFR-targeted antibody-based tracers that require infusion multiple days before surgery. Following their preclinical work, Dr. Henderson’s team completed a phase 0 microdose trial of ABY-029, evaluating tracer-associated contrast compared with the surrounding, nontumoral tissues.…”

Section: Phase 1 and Pilot Studiesmentioning

confidence: 99%

“…Following their preclinical work, Dr. Henderson’s team completed a phase 0 microdose trial of ABY-029, evaluating tracer-associated contrast compared with the surrounding, nontumoral tissues. 34 – 36 Preliminary data indicate that overall tumor contrast-to-normal tissue is 3.25. Fluorescence contrast was highest at the tumors’ periphery, with a TBR of 4.25 with a signal-to-noise ratio of 7.43.…”

Section: Phase 1 and Pilot Studiesmentioning

confidence: 99%

“…On ex vivo analysis, the sensitivity of the tracer was 82% (

if specimens from negative cases were excluded) and specificity was 89%. 34 …”

Section: Phase 1 and Pilot Studiesmentioning

confidence: 99%

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Intraoperative molecular imaging clinical trials: a review of 2020 conference proceedings

et al. 2021

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Significance: Surgery is often paramount in the management of many solid organ malignancies because optimal resection is a major factor in disease-specific survival. Cancer surgery has multiple challenges including localizing small lesions, ensuring negative surgical margins around a tumor, adequately staging patients by discriminating positive lymph nodes, and identifying potential synchronous cancers. Intraoperative molecular imaging (IMI) is an emerging potential tool proposed to address these issues. IMI is the process of injecting patients with fluorescenttargeted contrast agents that highlight cancer cells prior to surgery. Over the last 5 to 7 years, enormous progress has been achieved in tracer development, near-infrared camera approvals, and clinical trials. Therefore, a second biennial conference was organized at the University of Pennsylvania to gather surgical oncologists, scientists, and experts to discuss new investigative findings in the field. Our review summarizes the discussions from the conference and highlights findings in various clinical and scientific trials.Aim: Recent advances in IMI were presented, and the importance of each clinical trial for surgical oncology was critically assessed. A major focus was to elaborate on the clinical endpoints that were being utilized in IMI trials to advance the respective surgical subspecialties.Approach: Principal investigators presenting at the Perelman School of Medicine Abramson Cancer Center's second clinical trials update on IMI were selected to discuss their clinical trials and endpoints.Results: Multiple phase III, II, and I trials were discussed during the conference. Since the approval of 5-ALA for commercial use in neurosurgical malignancies, multiple tracers and devices have been developed to address common challenges faced by cancer surgeons across

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Phase 1 dose escalation and expansion safety study of BLZ-100 in pediatric subjects with primary central nervous system tumors.

Cited by 2 publications

References 0 publications

Targeted optical fluorescence imaging: a meta-narrative review and future perspectives

Targeted optical fluorescence imaging: a meta-narrative review and future perspectives

Intraoperative molecular imaging clinical trials: a review of 2020 conference proceedings

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