Phase 1 Study of 68Ga-R8760

NCT05999292 | Terminated Phase 1 FDA Drug

• 1 other identifier: R8760-101
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Adrenocortical Carcinoma

Keywords

Adrenocortical Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

  7 days

• Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs

  1 day

• The effective dose (milliSievert [mSv]/MBq)

  1 day

Secondary Outcomes (6)

• Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images

  1 day

• Maximum standard uptake value (SUVmax) of each tumor and of source organ

  1 day

• Ratio of the tumor SUV over reference region SUV

  1 day

• Area under the plasma concentration versus time curse (AUC)

  1 day

• Maximum plasma concentration (Cmax)

  1 day

Study Arms (2)

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

Interventions

68Ga-R8760 injection at pre-defined dose levels DRUG

PET/CT imaging at predefined timepoints

68Ga-R8760 Dose Selection (Part 1)

68Ga-R8760 injection DRUG

PET/CT imaging at a single timepoint

68Ga-R8760 Expansion Cohort (Part 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Radionetics Oncology: lead

Study Sites (2)

University of Michigan Nuclear Medicine

Ann Arbor, Michigan, 48109, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 21, 2023
• Study Start: September 11, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)