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Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

NCT06228482•University of California, Davis

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+5 more criteria

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

Locations (1)

The University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Key Dates

Start Date

January 22, 2024

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Nonsmall Cell Lung Cancer

Interventions

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

DRUG

Contacts

Julie L Sutcliffe, Phd

CONTACT

9167345536 jlsutcliffe@ucdavis.edu