Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

January 30, 2024 updated by: Julie L. Sutcliffe, Ph.D, University of California, Davis
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • The University of California Davis Comprehensive Cancer Center
        • Sub-Investigator:
          • Megan Daly, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: [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.
Other Names:
  • [68Ga]Ga DOTA-5G
  • [177Lu]Lu DOTA-ABM-5G
  • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[68Ga]Ga DOTA-5G PET/CT imaging
Time Frame: 2 hours from time of injection
To assess the ability of [68Ga]Ga DOTA-5G to detect lesions in patients with metastatic NSCLC
2 hours from time of injection
[177Lu]Lu DOTA-ABM-5G treatment
Time Frame: 30 days from time of treatment
To assess the safety and tolerability of a single treatment with [177Lu]Lu DOTA-ABM-5G
30 days from time of treatment
[177Lu]Lu DOTA-ABM-5G treatment efficacy
Time Frame: 60 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.
60 days from time of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Julie L Sutcliffe, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1778736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Nonsmall Cell Lung Cancer

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe