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Phase 1 Study of 68Ga-R8760

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05999292
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : October 31, 2023
Sponsor:
Information provided by (Responsible Party):
Radionetics Oncology

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

Condition or disease Intervention/treatment Phase
Adrenocortical Carcinoma Drug: 68Ga-R8760 injection at pre-defined dose levels Drug: 68Ga-R8760 injection Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients With Adrenocortical Carcinoma and Healthy Volunteers
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
68Ga-R8760 Dose Selection (Part 1) Drug: 68Ga-R8760 injection at pre-defined dose levels
PET/CT imaging at predefined timepoints
68Ga-R8760 Expansion Cohort (Part 2) Drug: 68Ga-R8760 injection
PET/CT imaging at a single timepoint


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Absorbed dose coefficients (mGy/MBq) in target organs and the effective dose coefficient (mSv/MBq) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images [ Time Frame: 1 day ]
  2. Maximum standard uptake value (SUVmax) of each tumor and of source organ [ Time Frame: 1 day ]
  3. Ratio of the tumor SUV over reference region SUV [ Time Frame: 1 day ]
  4. Area under the plasma concentration versus time curse (AUC) [ Time Frame: 1 day ]
  5. Maximum plasma concentration (Cmax) [ Time Frame: 1 day ]
  6. Half-life (T1/2) of 68Ga-R8760 [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Adrenocortical Carcinoma Subjects

Inclusion Criteria:

  1. Pathologically confirmed ACC.
  2. Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria.
  3. Male or non-pregnant, non-lactating female subjects age ≥18 years.
  4. 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.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.

  6. Adequate hepatic function as defined below:

    1. 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
    2. Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN).
  7. Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute).
  8. Able to understand and willing to sign a written informed consent form.

Exclusion Criteria:

  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.
  2. Radiotherapy ≤14 days prior to study Day 1.
  3. Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure.
  4. 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.
  5. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval >450 msec (males) or >470 msec (females).
  6. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
  7. History of other previous or concurrent cancer that would interfere with the determination of safety.
  8. Major active infection requiring antibiotics.
  9. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
  10. Acute illness within 14 days prior to study Day 1unless mild in severity, as assessed by the Investigator.
  11. 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:

  1. Healthy male or non-pregnant, non-lactating female subjects aged between 18 and 59 years (inclusive).
  2. 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.
  3. Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
  4. Adequate renal function as measured by creatinine clearance calculated at ≥60 mL/minute by the Cockcroft-Gault formula.
  5. Able to understand and willing to sign a written informed consent form.

Exclusion Criteria:

  1. Prior unilateral or bilateral adrenalectomy.
  2. Mental or legal incapacitation.
  3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  4. Subjects diagnosed with adrenal disease, including Cushing's syndrome, adrenal insufficiency, or congenital adrenal hyperplasia.
  5. Glucocorticoid steroid use (including topical) within 4 weeks prior to study Day 1 (inhaled steroids are allowed).
  6. Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections.
  7. Resting pulse rate ≥100 or <40 beats per minute at screening. If abnormal, a repeat measurement will be conducted to confirm.
  8. 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.
  9. 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.
  10. Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1.
  11. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05999292


Contacts
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Contact: Istvan Molnar, MD 201-912-6062 imolnar@radionetics.com
Contact: Adina Robinson 303-915-0344 arobinson@radionetics.com

Locations
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United States, Michigan
University of Michigan Nuclear Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James Pool    734-735-3130    jampool@med.umich.edu   
Principal Investigator: Benjamin Viglianti, MD PhD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Damaris Cruz-Goldberg    713-745-5691    Dcruz1@mdanderson.org   
Principal Investigator: Mouhammed A Habra, MD, FACP, FACE         
Sponsors and Collaborators
Radionetics Oncology
More Information
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Responsible Party: Radionetics Oncology
ClinicalTrials.gov Identifier: NCT05999292    
Other Study ID Numbers: R8760-101
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: October 31, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radionetics Oncology:
Adrenocortical Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
 Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases