Safety of an imaging agent in skin cancer

Background

We supported a Phase 1 clinical trial evaluating the safety and tolerability of a novel imaging agent BLZ-100 (tozuleristide) designed to highlight cancer cells in real-time during surgery. This innovative approach aimed to improve surgical outcomes for patients with skin cancer by enabling better visualization of cancerous tissue.

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Objective

To assess the safety, tolerability and feasibility of BLZ-100 in a clinical setting, laying the groundwork for further clinical development.

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Approach

Leveraging extensive early-stage clinical trial expertise, we provided strategic guidance on:

• trial design to align with regulatory requirements and clinical objectives
• practical implementation strategies for introducing an innovative imaging agent into real-world healthcare settings
• monitoring and analysis to ensure safety and efficacy outcomes were met.

Results

• Successful administration of BLZ-100 in 21 patients.
• No serious adverse events, deaths or discontinuations due to adverse events were reported.
• BLZ-100 was well tolerated at all dose levels tested, supporting further clinical studies.

Key takeaways

• Our expertise in early-phase clinical trial design and regulatory navigation ensured the trial met its objectives.
• Results validated the potential of BLZ-100 to enhance surgical outcomes in skin cancer patients.
• The value of integrating innovative diagnostic tools into oncology clinical trials was demonstrated.

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