Purpose

This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

[68Ga]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 or more years 3. Pathologically confirmed solid cancer with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis) or PERCIST. 4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging. 5. Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available. 6. Eastern Cooperative Oncology Group Performance Status ≤ 2 7. Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to [68Ga]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline. 8. Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL 9. Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN 10. Anticipated life expectancy ≥ 3 months 11. Able to remain motionless for up to 30-60 minutes per scan [177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria: 1. Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan 2. The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal SUVmax >2-fold above normal tissue at site of metastasis e.g. normal lung, bone, brain) and identified on standard of care diagnostic imaging)

Exclusion Criteria

[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G therapy Exclusion Criteria: 1. Participants with Class 3 or 4 NYHA Congestive Heart Failure 2. Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding) 3. Pregnant or lactating women 4. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks 5. Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix) 6. Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy 7. Psychiatric illness/social situations that would interfere with compliance with study requirements 8. Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.) 9. Pathologically confirmed NSCLC with metastatic disease 10. INR >2.0: PTT>15 seconds above ULN 11. Participant on therapeutic warfarin anticoagulation 12. External beam radiation therapy (EBRT) or radiopharmaceutical treatment within 21 days prior to study day 1

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single treatment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
[177Lu]Lu DOTA-ABM-5G single dose therapy study
Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy.
  • Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
    Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up [68Ga]Ga DOTA-5G PET/CT scans to assess tretament efficacy.
    Other names:
    • [68Ga]Ga DOTA-5G
    • [177Lu]Lu DOTA-ABM-5G
    • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair

Recruiting Locations

The University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Julie L Sutcliffe, PhD
916-734-5536
jlsutcliffe@health.ucdavis.edu

More Details

Status
Recruiting
Sponsor
University of California, Davis

Study Contact

Julie L Sutcliffe, Phd
9167345536
jlsutcliffe@health.ucdavis.edu

Detailed Description

This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. [68Ga]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the [177Lu]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue. The hypothesis are that a) [68Ga]Ga DOTA-5G will detect lesions in patients with metastatic cancer, b) the theranostic pair [68Ga]Ga DOTA-5G/ [177Lu]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of [177Lu]Lu DOTA-ABM-5G.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.