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Phase 1 Study of 68Ga-R8760

Primary Purpose

Adrenocortical Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
68Ga-R8760 injection at pre-defined dose levels
68Ga-R8760 injection
Sponsored by
Radionetics Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenocortical Carcinoma focused on measuring Adrenocortical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Adrenocortical Carcinoma Subjects Inclusion Criteria: Pathologically confirmed ACC. Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria. Male or non-pregnant, non-lactating female subjects age ≥18 years. Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. Adequate hepatic function as defined below: Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN). Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute). Able to understand and willing to sign a written informed consent form. Exclusion Criteria: Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1. Radiotherapy ≤14 days prior to study Day 1. Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting study drug, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval >450 msec (males) or >470 msec (females). History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability. History of other previous or concurrent cancer that would interfere with the determination of safety. Major active infection requiring antibiotics. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C. Acute illness within 14 days prior to study Day 1unless mild in severity, as assessed by the Investigator. Any other condition that in the opinion of the Investigator would place the subject at an unacceptable risk or cause the subject to be unlikely to fully participate or comply with study procedures. Healthy Volunteers Inclusion Criteria: Healthy male or non-pregnant, non-lactating female subjects aged between 18 and 59 years (inclusive). Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. Body mass index between 18.0 and 32.0 kg/m2 (inclusive). Adequate renal function as measured by creatinine clearance calculated at ≥60 mL/minute by the Cockcroft-Gault formula. Able to understand and willing to sign a written informed consent form. Exclusion Criteria: Prior unilateral or bilateral adrenalectomy. Mental or legal incapacitation. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Subjects diagnosed with adrenal disease, including Cushing's syndrome, adrenal insufficiency, or congenital adrenal hyperplasia. Glucocorticoid steroid use (including topical) within 4 weeks prior to study Day 1 (inhaled steroids are allowed). Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections. Resting pulse rate ≥100 or <40 beats per minute at screening. If abnormal, a repeat measurement will be conducted to confirm. Systolic blood pressure >160 or <90 mmHg or diastolic blood pressure >90 or <50 mmHg, unless judged by the Investigator to have no clinical significance. Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to study Day 1. Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1. Donation of blood or significant blood loss within 3 months prior to screening, donation of plasma within 2 weeks prior to screening, or donation of platelets within 6 weeks prior to screening.

Sites / Locations

  • University of Michigan Nuclear MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

68Ga-R8760 Dose Selection (Part 1)

68Ga-R8760 Expansion Cohort (Part 2)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters
Absorbed dose coefficients (mGy/MBq) in target organs and the effective dose coefficient (mSv/MBq)

Secondary Outcome Measures

Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images
Maximum standard uptake value (SUVmax) of each tumor and of source organ
Ratio of the tumor SUV over reference region SUV
Area under the plasma concentration versus time curse (AUC)
Maximum plasma concentration (Cmax)
Half-life (T1/2) of 68Ga-R8760

Full Information

First Posted
July 27, 2023
Last Updated
September 21, 2023
Sponsor
Radionetics Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05999292
Brief Title
Phase 1 Study of 68Ga-R8760
Official Title
Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients With Adrenocortical Carcinoma and Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radionetics Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma
Keywords
Adrenocortical Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-R8760 Dose Selection (Part 1)
Arm Type
Other
Arm Title
68Ga-R8760 Expansion Cohort (Part 2)
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
68Ga-R8760 injection at pre-defined dose levels
Intervention Description
PET/CT imaging at predefined timepoints
Intervention Type
Drug
Intervention Name(s)
68Ga-R8760 injection
Intervention Description
PET/CT imaging at a single timepoint
Primary Outcome Measure Information:
Title
Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters
Time Frame
7 days
Title
Absorbed dose coefficients (mGy/MBq) in target organs and the effective dose coefficient (mSv/MBq)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images
Time Frame
1 day
Title
Maximum standard uptake value (SUVmax) of each tumor and of source organ
Time Frame
1 day
Title
Ratio of the tumor SUV over reference region SUV
Time Frame
1 day
Title
Area under the plasma concentration versus time curse (AUC)
Time Frame
1 day
Title
Maximum plasma concentration (Cmax)
Time Frame
1 day
Title
Half-life (T1/2) of 68Ga-R8760
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Adrenocortical Carcinoma Subjects Inclusion Criteria: Pathologically confirmed ACC. Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria. Male or non-pregnant, non-lactating female subjects age ≥18 years. Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. Adequate hepatic function as defined below: Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN). Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute). Able to understand and willing to sign a written informed consent form. Exclusion Criteria: Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1. Radiotherapy ≤14 days prior to study Day 1. Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting study drug, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval >450 msec (males) or >470 msec (females). History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability. History of other previous or concurrent cancer that would interfere with the determination of safety. Major active infection requiring antibiotics. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C. Acute illness within 14 days prior to study Day 1unless mild in severity, as assessed by the Investigator. Any other condition that in the opinion of the Investigator would place the subject at an unacceptable risk or cause the subject to be unlikely to fully participate or comply with study procedures. Healthy Volunteers Inclusion Criteria: Healthy male or non-pregnant, non-lactating female subjects aged between 18 and 59 years (inclusive). Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. Body mass index between 18.0 and 32.0 kg/m2 (inclusive). Adequate renal function as measured by creatinine clearance calculated at ≥60 mL/minute by the Cockcroft-Gault formula. Able to understand and willing to sign a written informed consent form. Exclusion Criteria: Prior unilateral or bilateral adrenalectomy. Mental or legal incapacitation. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Subjects diagnosed with adrenal disease, including Cushing's syndrome, adrenal insufficiency, or congenital adrenal hyperplasia. Glucocorticoid steroid use (including topical) within 4 weeks prior to study Day 1 (inhaled steroids are allowed). Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections. Resting pulse rate ≥100 or <40 beats per minute at screening. If abnormal, a repeat measurement will be conducted to confirm. Systolic blood pressure >160 or <90 mmHg or diastolic blood pressure >90 or <50 mmHg, unless judged by the Investigator to have no clinical significance. Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to study Day 1. Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1. Donation of blood or significant blood loss within 3 months prior to screening, donation of plasma within 2 weeks prior to screening, or donation of platelets within 6 weeks prior to screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Istvan Molnar, MD
Phone
201-912-6062
Email
imolnar@radionetics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adina Robinson
Phone
303-915-0344
Email
arobinson@radionetics.com
Facility Information:
Facility Name
University of Michigan Nuclear Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Pool
Phone
734-735-3130
Email
jampool@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Viglianti, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase 1 Study of 68Ga-R8760

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