Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

BLZ-100

Kristi M Harrington, MD

Surgery is the primary treatment modality for many types of cancer and the extent of surgical resection is directly related to patient survival. However, it is often difficult for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid damage to critical normal tissues. The purpose of this exploratory study is to evaluate the intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with breast cancer.

Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study.

Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.

All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs.

Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.

Exploratory Study of Safety and ex Vivo Fluorescence of BLZ-100 in Adult Subjects With Solid Tumors Undergoing Surgery

A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery

Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. These assessments will be used to determine whether a subject experienced an AE.

Ex vivo fluorescence of excised tumor specimens will be evaluated with the SIRIS or equivalent imaging device and Odyssey imaging system.

BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.

Blaze Bioscience Inc.

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Sarah Leary, MD, MS

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. The investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as they operate. This is a safety study to assess the safety of BLZ-100 in pediatric patients with central nervous system tumors.

Subjects who provide voluntary written informed consent, or have it provided by their legally acceptable representative, will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.

Subjects will be required to arrive at the hospital for dosing at least 1 hour before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 1 hour after study product administration.

Study of BLZ-100 in Pediatric Subjects With CNS Tumors

A Phase 1 Dose-escalation and Expansion Study of BLZ-100 in Pediatric Subjects With Primary Central Nervous System Tumors

Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.

Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.

For subjects enrolled in the expansion cohort, an extent of resection assessment will be made by the surgeon and confirmed by post-operative MRI according to standard of care procedures.

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All participants in the study will receive the investigational drug product BLZ-100.

In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window.

In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose).

All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors.

Three different imaging windows will be investigated during the study:

Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose)

All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups.

Charles Forscher, MD

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue, and failure to surgically remove a cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in significant morbidity. The investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as they operate. This is a safety study to assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.

Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.

This is a two part study:

Part 1 - Dose Finding: Subjects will be required to arrive at the phase 1 unit for dosing 2-3 days prior to the planned surgical excision. Two dose levels of BLZ-100 (3 mg and 12 mg) will be evaluated in a total of 6 subjects with a 2-3 day post-dose imaging interval (also defined as the Intermediate Imaging interval).

Part 2 - Imaging Interval Assessment: The BLZ-100 dose to be evaluated in Part 2 will be determined by the Protocol Steering Committee following completion of Part 1. In Part 2, up to 15 additional subjects will be randomized into one of three imaging interval groups (up to 6 subjects per group): Early Imaging (within 1 day post BLZ-100 dose), Intermediate Imaging (2-3 days post BLZ-100 dose), and Late Imaging (4-7 days post BLZ-100 dose). Subjects will be required to arrive at the phase 1 unit for dosing between 1 and 7 days prior to planned surgical excision, depending on which imaging interval they are randomized to.

Following dosing, all subjects will be monitored for safety.

Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery

A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery

Fluorescent signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.

Fluorescent signal will be evaluated in sections of excised tumor and adjacent normal tissue to determine which imaging interval provides the optimal images.

National Cancer Institute (NCI)

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Chirag Patil

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas undergoing surgery.

Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.

Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for dosing at least 2 hours before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 2 hours after study product administration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exploratory Study of Safety and ex Vivo Fluorescence of BLZ-100 in Adult Subjects With Solid Tumors Undergoing Surgery	NCT02496065	Tumors, Breast	BLZ-100	18 Years -	Blaze Bioscience Inc.
Study of BLZ-100 in Pediatric Subjects With CNS Tumors	NCT02462629	Central Nervous...	BLZ-100	1 Month - 30 Years	Blaze Bioscience Inc.
Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery	NCT02464332	Sarcoma, Soft T...	BLZ-100	18 Years - 75 Years	Blaze Bioscience Inc.
Study of BLZ-100 in Pediatric Subjects With CNS Tumors	NCT02462629	Central Nervous...	BLZ-100	1 Month - 30 Years	Blaze Bioscience Inc.
Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery	NCT02234297	Glioma	BLZ-100	18 Years - 75 Years	Blaze Bioscience Inc.

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Every month we try and update this database with for tumor paint cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for tumor paint

Every month we try and update this database with for tumor paint cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tumor paint cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.