Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ \[68Ga\]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.

Locations
United States
California
The University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Contact Information
Primary
Julie L Sutcliffe, Phd
jlsutcliffe@ucdavis.edu
9167345536
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2026-01
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Collaborators: United States Department of Defense
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov

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