Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
a study on Lung Cancer Non-Small Cell Lung Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedcompletion around
- Principal Investigator
- by Julie L Sutcliffe, PhD (ucdavis)
Description
Summary
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 non small cell lung cancer (NSCLC).
Details
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 NSCLC. [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 NSCLC 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.
We hypothesize that a) [68Ga]Ga DOTA-5G will detect lesions in patients with metastatic NSCLC, 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.
Keywords
Metastatic Nonsmall Cell Lung Cancer, integrin, metastatic NSCLC, PET, theranostic, Non-Small-Cell Lung Carcinoma, 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Eligibility
You can join if…
Open to people ages 18 years and up
[68Ga]Ga DOTA-5G PET/CT Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 or more years
- Pathologically confirmed NSCLC 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)
- Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen as established by diagnostic imaging.
- Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- 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.
Hematologic parameters defined as:
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
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
- Anticipated life expectancy ≥ 3 months
- Able to remain motionless for up to 30-60 minutes per scan
[177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria:
- Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
- The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain MRI as per standard of care for patients with metastatic NSCLC.
You CAN'T join if...
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G therapy Exclusion Criteria:
- Participants with Class 3 or 4 NYHA Congestive Heart Failure
- Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
- Pregnant or lactating women
- 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
- 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)
- Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
- Psychiatric illness/social situations that would interfere with compliance with study requirements
- Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
- Known interstitial lung disease or pre-existing pulmonary fibrosis
- INR >2.0: PTT>15 seconds above ULN
Location
- The University of California Davis Comprehensive Cancer Center
accepting new patients
Sacramento California 95817 United States
Lead Scientist at University of California Health
- Julie L Sutcliffe, PhD (ucdavis)
Professor, Hematology and Oncology, School of Medicine. Authored (or co-authored) 64 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, Davis
- ID
- NCT06228482
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 40 study participants
- Last Updated