Unlocking Hope for Cancer Patients Using PDT
PHASE 1/2 NON-MELANOMA SKIN CANCER TRIAL DESIGN1
ADAPTIVE DESIGN: SAFETY AND TOLERABILITY, DOSE OPTIMISATION, EFFICACY
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Increased Optionality: Open label adaptive trial design (3+3 light dose / dose light interval escalation²)
enables flexibility in size and timing, with option for repeat treatment depending on response
⚫ Ahead of the Curve: Earlier parts focus more on safety and tolerability, later parts more on dose and
schedule optimization, and efficacy
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Significant Cancer Market: Cutaneous Squamous Cell Carcinoma (cSCC) and superficial Basal Cell
Carcinoma (SBCC)
ENDPOINTS
Part 1
Light Dose, 3+3
Dose-Escalation*
Part 2
Part 3
Dose
Expansion***
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Safety and tolerability including
Dose Limiting toxicity (DLT)
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Dose Light Interval
Optimisation
Light dose, dose light interval
investigations
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(Optional**)
Anti-tumour activity
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Pharmacodynamic investigations
(exploratory)
INV043 dose is fixed at 0.5% w/w ointment for dermal application.
Wavelength: 660 nm; Intensity: 100 mW/cm²
*
**
If suboptimal clinical activity is noted in Part 1, the Safety Review Committee (SRC) may decide to open enrolment in Part 2 to optimise the DLI for PDT with INV043 at
any light dose level that has been deemed to be safe by the SRC
Following completion of at least 1 cohort in Part 2, SRC may decide to return to escalate the light dose and re-open Part 1 light dose escalation
*** Part 3 of study will investigate the anti-tumour activity of PDT, further assess the safety and tolerability of INV043 given at the recommended doses for future
exploration of the light dose and DLI determined in Part 1 and (if applicable) the DLI in Part 2
1 Subject to Human Research Ethics Committee (HREC) approval
2 In a "3+3 design," three patients are initially enrolled into a given dose cohort. If there is no DLT (dose limiting toxicity) observed in any of these subjects,
the trial proceeds to enroll additional subjects into the next higher dose cohort.
INVIONView entire presentation