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Radiopharmaceutical
Alpha Particle Radiotherapy for Eye Cancer
Phase 1
Recruiting
Led By Nikhil I Khushalani, MD
Research Sponsored by Modulation Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acceptable organ and marrow function as defined below: Leucocytes ≥ 3,000/μL, Absolute neutrophil count ≥ 1,500/μL, Platelets ≥ 100,000/μL, Aspartate aminotransferase AST/ Alanine aminotransferase ALT ≤ 2.5x institutional upper limit of normal (ULN), Bilirubin ≤ 1.5x institutional upper limit of normal (ULN), Creatinine clearance ≥ 60mL/min/1.73m^2 (measured by Cockcroft-Gault equation using actual body weight in kilograms, and then adjusted for body surface area)
Male participants who are sexually active, and female participants of childbearing potential must agree to use 2 forms of FDA approved contraceptive methods during treatment with 225Ac-MTI-201 and up to 3 months following treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of signing the informed consent document until death, or lost to follow-up (approximately 3 years)
Awards & highlights
Study Summary
This trial is testing a new drug to treat uveal melanoma, a type of eye cancer. They want to find the highest dose of the drug that people can tolerate, and also learn more about how the drug works in the body and what side effects it causes.
Who is the study for?
Adults with metastatic uveal melanoma who've had at least one prior treatment can join. They must have good performance status, measurable disease, and proper organ/marrow function. Participants need to use two forms of contraception if applicable and sign consent. Excluded are pregnant/nursing women, those with uncontrolled illnesses or certain other cancers, prior alpha-particle therapy recipients, and individuals with symptomatic brain metastases or significant immunocompromise.Check my eligibility
What is being tested?
The trial is testing different doses of a radiotherapy drug called 225Ac-MTI-201 to find the highest dose patients can tolerate without severe side effects (MTD). It also looks at how the body processes the drug and its toxic effects in those with metastatic uveal melanoma.See study design
What are the potential side effects?
Potential side effects include radiation-related risks such as damage to nearby tissues or organs, blood count changes that could lead to anemia or infection risk increase, fatigue from radiation exposure, nausea or vomiting. Specific side effect profiles will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function.
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I agree to use two forms of birth control during and up to 3 months after treatment.
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My uveal melanoma has worsened after at least one treatment.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is a type of melanoma that started in the eye and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of signing the informed consent document until death, or lost to follow-up (approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of signing the informed consent document until death, or lost to follow-up (approximately 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of 225Ac-MTI-201
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Secondary outcome measures
Number of Participants Who Experienced a Complete Response (CR), Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) According to Tumor Lesion Measurement
Observed Rate of Elimination from Blood of 225Ac-MTI-201
Observed Rate of Renal Elimination of 225Ac-MTI-201
Trial Design
12Treatment groups
Experimental Treatment
Group I: 225Ac-MTI-201 998 microCiExperimental Treatment1 Intervention
Cohort 11: Participants were administered a single dose of 998 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group II: 225Ac-MTI-201 9.5 microCiExperimental Treatment1 Intervention
Cohort 2: Participants were administered a single dose of 9.5 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group III: 225Ac-MTI-201 76 microCiExperimental Treatment1 Intervention
Cohort 5: Participants were administered a single dose of 76 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group IV: 225Ac-MTI-201 750 microCiExperimental Treatment1 Intervention
Cohort 10: Participants were administered a single dose of 750 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group V: 225Ac-MTI-201 564 microCiExperimental Treatment1 Intervention
Cohort 9: Participants were administered a single dose of 564 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group VI: 225Ac-MTI-201 424 microCiExperimental Treatment1 Intervention
Cohort 8: Participants were administered a single dose of 424 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group VII: 225Ac-MTI-201 4.7 microCiExperimental Treatment1 Intervention
Cohort 1: Participants were administered a single dose of 4.7 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group VIII: 225Ac-MTI-201 38 microCiExperimental Treatment1 Intervention
Cohort 4: Participants were administered a single dose of 38 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group IX: 225Ac-MTI-201 254 microCiExperimental Treatment1 Intervention
Cohort 7: Participants were administered a single dose of 254 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group X: 225Ac-MTI-201 19 microCiExperimental Treatment1 Intervention
Cohort 3: Participants were administered a single dose of 19 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group XI: 225Ac-MTI-201 152 microCiExperimental Treatment1 Intervention
Cohort 6: Participants were administered a single dose of 152 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Group XII: 225Ac-MTI-201 1327 microCiExperimental Treatment1 Intervention
Cohort 12: Participants were administered a single dose of 1327 microCi of 225Ac-MTI-201 via intravenous catheter, with up to 3 years of follow-up.
Find a Location
Who is running the clinical trial?
Modulation Therapeutics, Inc.Lead Sponsor
H. Lee Moffitt Cancer Center and Research InstituteOTHER
542 Previous Clinical Trials
135,476 Total Patients Enrolled
Nikhil I Khushalani, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
133 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received alpha-particle therapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My blood tests show normal organ function.I agree to use two forms of birth control during and up to 3 months after treatment.I am not pregnant or nursing, and if capable of childbearing, I have a recent negative pregnancy test.I have stable brain metastases, not including carcinomatous meningitis, and am on low-dose steroids or none.I have had radiation therapy to over 25% of my bone marrow.My uveal melanoma has worsened after at least one treatment.I am 18 years old or older.I am not immunocompromised due to HIV, certain conditions, or high-dose steroids.I have another active cancer that needs treatment and could affect my melanoma study results.You need to have a disease that can be measured according to specific medical guidelines.I am fully active or can carry out light work.My cancer is a type of melanoma that started in the eye and has spread.
Research Study Groups:
This trial has the following groups:- Group 1: 225Ac-MTI-201 254 microCi
- Group 2: 225Ac-MTI-201 998 microCi
- Group 3: 225Ac-MTI-201 750 microCi
- Group 4: 225Ac-MTI-201 424 microCi
- Group 5: 225Ac-MTI-201 564 microCi
- Group 6: 225Ac-MTI-201 1327 microCi
- Group 7: 225Ac-MTI-201 19 microCi
- Group 8: 225Ac-MTI-201 38 microCi
- Group 9: 225Ac-MTI-201 76 microCi
- Group 10: 225Ac-MTI-201 152 microCi
- Group 11: 225Ac-MTI-201 4.7 microCi
- Group 12: 225Ac-MTI-201 9.5 microCi
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the 4.7 microCi 225Ac-MTI-201 received regulatory authorization from the FDA?
"Our team at Power has assigned a score of 1 to 4.7 microCi 225Ac-MTI-201, as this is an experimental drug and there exists only minimal clinical evidence for its safety or efficacy."
Answered by AI
How many individuals are partaking in the examination of this clinical experiment?
"Affirmative. According to the details furnished on clinicaltrials.gov, this trial is still recruiting participants and was originally posted on July 21st 2022; with its most recent update occuring August 9th 2022. Currently, 16 patients are needed from a single medical centre for enrolment in this study."
Answered by AI
Are there still opportunities to partake in this scientific experiment?
"According to the details hosted on clinicaltrials.gov, this research initiative is still recruiting participants; first posted in July of 2022 and updated recently at the start of August."
Answered by AI
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