225Ac-MTI-201 998 microCi for Melanoma, Uveal

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Melanoma, Uveal+3 More
19 microCi of 225Ac-MTI-201 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary aim of the study is to establish the maximum-tolerated dose (MTD) of 225Ac-MTI-201 in participants with metastatic uveal melanoma. The secondary aims are to describe the pharmacokinetics of 225Ac-MTI-201 and the toxic effects of 225Ac-MTI-201 in participants with metastatic uveal melanoma.

Eligible Conditions

  • Melanoma, Uveal
  • Metastatic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Melanoma, Uveal

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: From time of signing the informed consent document until death, or lost to follow-up (approximately 3 years)

Hour 24
Observed Rate of Renal Elimination of 225Ac-MTI-201
Year 3
Number of Participants Who Experienced a Complete Response (CR), Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) According to Tumor Lesion Measurement
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Day 15
Observed Rate of Elimination from Blood of 225Ac-MTI-201
Week 4
Maximum Tolerated Dose (MTD) of 225Ac-MTI-201
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Other trials for Melanoma, Uveal

Trial Design

12 Treatment Groups

225Ac-MTI-201 998 microCi
1 of 12
225Ac-MTI-201 750 microCi
1 of 12
225Ac-MTI-201 254 microCi
1 of 12
225Ac-MTI-201 4.7 microCi
1 of 12
225Ac-MTI-201 564 microCi
1 of 12
225Ac-MTI-201 152 microCi
1 of 12
225Ac-MTI-201 76 microCi
1 of 12
225Ac-MTI-201 424 microCi
1 of 12
225Ac-MTI-201 9.5 microCi
1 of 12
225Ac-MTI-201 38 microCi
1 of 12
225Ac-MTI-201 19 microCi
1 of 12
225Ac-MTI-201 1327 microCi
1 of 12
Experimental Treatment

16 Total Participants · 12 Treatment Groups

Primary Treatment: 225Ac-MTI-201 998 microCi · No Placebo Group · Phase 1

225Ac-MTI-201 998 microCi
Drug
Experimental Group · 1 Intervention: 998 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 750 microCi
Drug
Experimental Group · 1 Intervention: 750 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 254 microCi
Drug
Experimental Group · 1 Intervention: 254 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 4.7 microCi
Drug
Experimental Group · 1 Intervention: 4.7 microCi 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 564 microCi
Drug
Experimental Group · 1 Intervention: 564 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 152 microCi
Drug
Experimental Group · 1 Intervention: 152 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 76 microCi
Drug
Experimental Group · 1 Intervention: 76 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 424 microCi
Drug
Experimental Group · 1 Intervention: 424 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 9.5 microCi
Drug
Experimental Group · 1 Intervention: 9.5 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 38 microCi
Drug
Experimental Group · 1 Intervention: 38 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 19 microCi
Drug
Experimental Group · 1 Intervention: 19 microCi of 225Ac-MTI-201 · Intervention Types: Drug
225Ac-MTI-201 1327 microCi
Drug
Experimental Group · 1 Intervention: 1327 microCi of 225Ac-MTI-201 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from time of signing the informed consent document until death, or lost to follow-up (approximately 3 years)
Closest Location: H. Lee Moffitt Cancer Center and Research Institute · Tampa, FL
Photo of Tampa  1Photo of Tampa  2Photo of Tampa  3
2013First Recorded Clinical Trial
1 TrialsResearching Melanoma, Uveal
320 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an adult age of at least 18 years.\n
You have a performance status of 0-1 (Karnofsky ≥ 70 percent).
AST/ALT ratio > 2.5x institutional ULN.

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.