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Radiopharmaceutical

[177Lu]Lu DOTA-ABM-5G single dose therapy study for Non-Small Cell Lung Cancer

Phase 1

Recruiting

Led By Julie L Sutcliffe, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group Performance Status ≤ 2

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days from time of treatment

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a pair of drugs called [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in patients

Who is the study for?

This trial is for patients with advanced non-small cell lung cancer that has spread to other parts of the body. Participants should be adults who have tried previous treatments without success and are now looking for new options.Check my eligibility

What is being tested?

The study is testing two related drugs, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G, to see if they're safe and effective in treating metastatic lung cancer. It's an early-phase trial, meaning it's one of the first times these drugs are being given to people.See study design

What are the potential side effects?

As this is a Phase I trial primarily focused on safety, specific side effects aren't listed yet but may include typical reactions from radionuclide therapies such as nausea, fatigue, or radiation-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My lung cancer has spread and can be measured by scans.

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My cancer can be measured by a specific PET/CT scan and I've had a brain MRI if there were concerns about brain metastases.

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My cancer has worsened after treatment as shown by scans.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days from time of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days from time of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days from time of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

[177Lu]Lu DOTA-ABM-5G treatment

[177Lu]Lu DOTA-ABM-5G treatment efficacy

[68Ga]Ga DOTA-5G PET/CT imaging

Side effects data

From 2011 Phase 1 & 2 trial • 26 Patients • NCT00142415

67%

Leukopenia

67%

Dizziness

67%

Fatigue

67%

Decreased appetite

33%

Weight decreased

33%

Diarrhoea

33%

Haemoptysis

33%

Thrombocytopenia

33%

Nausea

33%

Upper respiratory tract inflammation

33%

Vomiting

33%

Pain in extremity

33%

Tachycardia

33%

Constipation

33%

Anaemia

33%

Cough

33%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250

Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250

Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250

Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250

Total

Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250

Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250

Trial Design

1Treatment groups

Experimental Treatment

Group I: [177Lu]Lu DOTA-ABM-5G single dose therapy studyExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,479 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,659 Total Patients Enrolled

Julie L Sutcliffe, PhDPrincipal InvestigatorUniversity of California, Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the process of enrolling participants currently underway for this clinical trial?

"Indeed, according to the information provided on clinicaltrials.gov, this study is currently in search of eligible participants. The trial was initially listed on January 17th, 2024 and recently updated on January 18th, 2024. A total of 40 patients will be enrolled from a single site."

Answered by AI

What is the current number of individuals receiving treatment within this specific clinical trial?

"Indeed, the information provided on clinicaltrials.gov affirms that this investigation is presently seeking suitable participants. The initial posting of this trial occurred on January 17th, 2024, and it was last modified on January 18th, 2024. To fulfill its objectives, a total of 40 individuals are sought after from one designated locale."

Answered by AI

Has the [177Lu]Lu DOTA-ABM-5G single dose treatment trial received official authorization from the FDA?

"Considering that this is a Phase 1 trial, there is limited data supporting the safety and effectiveness of [177Lu]Lu DOTA-ABM-5G single dose therapy study. Therefore, our team at Power rates its safety as 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Julie L. Sutcliffe, Ph.D 2024. "Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06228482.

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