RecruitingPhase 1NCT06228482
Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
Sponsor
University of California, Davis
Enrollment
40 participants
Start Date
Jan 22, 2024
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria15
- 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
- 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.
Exclusion Criteria10
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06228482