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NCT06228482 | RECRUITING | Metastatic Nonsmall Cell Lung Cancer

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
Sponsor:

University of California, Davis

Information provided by (Responsible Party):

Julie L. Sutcliffe, Ph.D

Brief 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).

Condition or disease

Metastatic Nonsmall Cell Lung Cancer

Intervention/treatment

[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Phase

PHASE1

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 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
Actual Study Start Date : 2024-01-22
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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)
    • 4. 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.
    • 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 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 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. Known interstitial lung disease or pre-existing pulmonary fibrosis
            • 10. INR \>2.0: PTT\>15 seconds above ULN
Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Location Details

NCT06228482

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Locations

RECRUITING

United States, California

The University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817