Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Share Trial

Download Trial

Is this your trial?

If this is your trial and you’d like to update the information or upload supporting documentation, please contact Ancora.ai

Download Trial

Source: NCT06228482

Recruiting

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Lung Cancer

Phase 1

The University of California Davis Comprehensive Cancer Center

United States of America

Sponsor: University of California, Davis

Last Updated: February 27, 2026
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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).

Show Detailed Description

Study Type

Theranostic

Radiation

Beta, Positron

Radiopharmaceutical

Ga-68 DOTA-5G, Lu-177 DOTA-ABM-5G

Target

Integrin αvβ6

Trial Started

January 22, 2024

Last Updated by Sponsor

February 27, 2026

Estimated Completion

January 1, 2027

Eligibility

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

[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

Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll40

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

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

Outcome Measures

Primary Outcome Measures

[68Ga]Ga DOTA-5G PET/CT imaging2 hours from time of injection

To assess the ability of [68Ga]Ga DOTA-5G to detect lesions in patients with metastatic NSCLC

[177Lu]Lu DOTA-ABM-5G treatment30 days from time of treatment

To assess the safety and tolerability of a single treatment with [177Lu]Lu DOTA-ABM-5G

[177Lu]Lu DOTA-ABM-5G treatment efficacy60 days from time of treatment

To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second [68Ga]Ga DOTA-5G PET/CT, prior to next line of therapy.

Secondary Outcome Measures

None

Trial Sites

This study has 1 trial site

The University of California Davis Comprehensive Cancer Center
Sacramento, California, US

Loading Maps...