Dose escalation for Malignant Melanoma of Skin

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Health Network - Princess Margaret Cancer Centre, Toronto, Canada
Malignant Melanoma of Skin+7 More
[Ga-68]-PNT6555 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This Phase 1 study will evaluate the safety and tolerability of [Ga-68]-PNT6555 and [Lu-177]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.

Eligible Conditions

  • Malignant Melanoma of Skin
  • Esophageal Neoplasms Malignant
  • Soft Tissue Sarcoma (STS)
  • Colorectal Carcinoma (CRC)
  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From first dose of study drug until disease progression (up to approximately 3 years)

Day 7
Adverse events for [Ga-68]-PNT6555
Biodistribution and radiation dosimetry of [Ga-68]-PNT6555 to normal organs.
Detection of [Ga-68]-PNT6555 in tumor lesions
Uptake of [Ga-68]-PNT6555 in tumor lesions
From first dose of imaging study drug through two hours post dose
Uptake of the [Ga-68]-PNT6555 imaging agent and optimal scanning specifications for future studies
Week 24
Biodistribution and radiation dosimetry of [Lu-177]-PNT6555 to normal organs.
Preliminary efficacy of [Lu-177]-PNT6555 based on change in biomarkers.
Radiation dosimetry of [Lu-177]-PNT6555 to tumor lesions.
Treatment emergent adverse events
Tumor immune response to administration of [Lu-177]-PNT6555.
Year 3
Preliminary efficacy of [Lu-177]-PNT6555 based on tumor response.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Dose escalation
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Dose escalation · No Placebo Group · Phase 1

Dose escalationExperimental Group · 2 Interventions: [Ga-68]-PNT6555, [Lu-177]-PNT6555 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study drug until disease progression (up to approximately 3 years)
Closest Location: University Health Network - Princess Margaret Cancer Centre · Toronto, Canada
Photo of Toronto  1Photo of Toronto  2Photo of Toronto  3
2014First Recorded Clinical Trial
1 TrialsResearching Malignant Melanoma of Skin
11 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female of childbearing potential and male of childbearing potential.
Platelets greater than 120,000/ mm^3 at dosing.
You are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
You have read, understood, and signed the informed consent form(s).
You are male or female and are between the ages of 18 and 80 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.