CompletedPhase 1

A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis

United States13 participantsStarted 2021-11-30

Plain-language summary

This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Understands the study procedures and capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
✓. Male or female ≥18 years of age.
✓. Has a confirmed diagnosis of Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), or Leukocyte chemotactic factor 2 amyloidosi (ALECT2), or any other forms of systemic amyloidosis based on any one of the following:
✓. a histologic confirmation with a biopsy containing deposits of apple-green birefringent, congophilic material;
✓. genetic screening with presence of amyloid-related pathology; and/or
✓. amyloid-specific imaging study.
✓. Has known involvement of at least one thoracoabdominal organ (excluding peripheral nervous system) by clinical history (e.g., imaging consistent with amyloid deposition, organ biopsy, elevated amyloid-related biomarkers, etc.).
✓. For women of childbearing potential: agreement to remain as abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 90 days after the last dose of study intervention.

Exclusion criteria

✕. Is pregnant or breast-feeding.
✕. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
✕. Has participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the 4 months prior to Screening.
✕. Has a significant co-morbidity (e.g., ECOG score of 3 or greater), NYHA Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
✕. Has a known allergy to iOSAT iodine treatment.
✕. Has end-stage renal disease and is receiving hemodialysis or peritoneal dialysis.
✕. Has received an investigational agent within five half-lives of the agent or 30 days, whichever is longer, prior to Screening.
✕. Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.

What they're measuring

To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.

Timeframe: Day 4.

To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.

Timeframe: Day 6.

Trial details

NCT IDNCT05201911

SponsorAttralus, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-06

View on ClinicalTrials.gov More Amyloidosis; Systemic trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Understands the study procedures and capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
✓. Male or female ≥18 years of age.
✓. Has a confirmed diagnosis of Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), or Leukocyte chemotactic factor 2 amyloidosi (ALECT2), or any other forms of systemic amyloidosis based on any one of the following:
✓. a histologic confirmation with a biopsy containing deposits of apple-green birefringent, congophilic material;
✓. genetic screening with presence of amyloid-related pathology; and/or
✓. amyloid-specific imaging study.
✓. Has known involvement of at least one thoracoabdominal organ (excluding peripheral nervous system) by clinical history (e.g., imaging consistent with amyloid deposition, organ biopsy, elevated amyloid-related biomarkers, etc.).
✓. For women of childbearing potential: agreement to remain as abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 90 days after the last dose of study intervention.

Exclusion criteria

✕. Is pregnant or breast-feeding.
✕. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
✕. Has participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the 4 months prior to Screening.
✕. Has a significant co-morbidity (e.g., ECOG score of 3 or greater), NYHA Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
✕. Has a known allergy to iOSAT iodine treatment.
✕. Has end-stage renal disease and is receiving hemodialysis or peritoneal dialysis.
✕. Has received an investigational agent within five half-lives of the agent or 30 days, whichever is longer, prior to Screening.
✕. Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.

What they're measuring

To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.

Timeframe: Day 4.

To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.

Timeframe: Day 6.