Adrenocortical CarcinomaPhase 1NCT05999292
Phase 1 Study of 68Ga-R8760
A Phase 1 study testing 68Ga-R8760 injection at pre-defined dose levels and 68Ga-R8760 injection in people with Adrenocortical Carcinoma, run by Radionetics Oncology at 2 sites in United States.
Trial summary
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adrenocortical Carcinoma
- What is being tested?
- 68Ga-R8760 injection at pre-defined dose levels and 68Ga-R8760 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2023to 23 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathologically or clinically 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:
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- 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.
- 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.
Who cannot join
- 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.
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- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Nuclear Medicine
Ann Arbor, Michigan, 48109
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients With Adrenocortical Carcinoma and Healthy Volunteers
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
- Conditions
- Adrenocortical Carcinoma
- Being tested
- 68Ga-R8760 injection at pre-defined dose levels, 68Ga-R8760 injection
- Keywords
- Adrenocortical Carcinoma
- Medical subject headings
- Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-R8760 injection at pre-defined dose levelsDrug
PET/CT imaging at predefined timepoints
68Ga-R8760 injectionDrug
PET/CT imaging at a single timepoint
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-R8760 Dose Selection (Part 1) | Other | Not described Receives: Drug: 68Ga-R8760 injection at pre-defined dose levels |
| 68Ga-R8760 Expansion Cohort (Part 2) | Other | Not described Receives: Drug: 68Ga-R8760 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs
Measured: 1 day
The effective dose (milliSievert [mSv]/MBq)
Measured: 1 day
Secondary outcomes (6)
Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images
Measured: 1 day
Maximum standard uptake value (SUVmax) of each tumor and of source organ
Measured: 1 day
Ratio of the tumor SUV over reference region SUV
Measured: 1 day
Area under the plasma concentration versus time curse (AUC)
Measured: 1 day
Maximum plasma concentration (Cmax)
Measured: 1 day
Half-life (T1/2) of 68Ga-R8760
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start11 Sep 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radionetics Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999292
- Sponsor's protocol ID
- R8760-101
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients With Adrenocortical Carcinoma and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05999292
- Acronym / sponsor ID
- R8760-101
- Conditions
- Adrenocortical Carcinoma
- Keywords
- Adrenocortical Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Radionetics OncologyIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-R8760 Dose Selection (Part 1) | Other | Drug: 68Ga-R8760 injection at pre-defined dose levels |
| 68Ga-R8760 Expansion Cohort (Part 2) | Other | Drug: 68Ga-R8760 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically or clinically 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.
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-R8760 injection at pre-defined dose levelsPET/CT imaging at predefined timepoints | Drug | 68Ga-R8760 Dose Selection (Part 1) |
| 68Ga-R8760 injectionPET/CT imaging at a single timepoint | Drug | 68Ga-R8760 Expansion Cohort (Part 2) |
Primary outcome
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
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs
Time frame: 1 day
The effective dose (milliSievert [mSv]/MBq)
Time frame: 1 day
6 secondary outcomes
Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images
Time frame: 1 day
Maximum standard uptake value (SUVmax) of each tumor and of source organ
Time frame: 1 day
Ratio of the tumor SUV over reference region SUV
Time frame: 1 day
Area under the plasma concentration versus time curse (AUC)
Time frame: 1 day
Maximum plasma concentration (Cmax)
Time frame: 1 day
Half-life (T1/2) of 68Ga-R8760
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-R8760 injection at pre-defined dose levels and 68Ga-R8760 injection in people with Adrenocortical Carcinoma, run by Radionetics Oncology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.