Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

NCT ID: NCT06228482

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2026-01-31

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).

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.

Conditions

Metastatic Nonsmall Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

[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.

Intervention Type: DRUG

Other Intervention Names

[68Ga]Ga DOTA-5G; [177Lu]Lu DOTA-ABM-5G; [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Julie L. Sutcliffe, Ph.D

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie L Sutcliffe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

The University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie L Sutcliffe, Phd

Role: CONTACT

jlsutcliffe@ucdavis.edu

9167345536

Facility Contacts

Julie L Sutcliffe, PhD

Role: primary

jlsutcliffe@ucdavis.edu

916-734-5536

Other Identifiers

1778736

Identifier Type: -

Identifier Source: org_study_id