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Radiopharmaceutical

Molecularly Targeted Therapy for Advanced Cancer

Phase 1

Recruiting

Led By Julie L Sutcliffe

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

Age 18 or more years

Pathologically confirmed GU, GI, breast, cervical, uterine, or head and neck cancers 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)

Must not have

Participant on therapeutic warfarin anticoagulation

Participants with Class 3 or 4 NYHA Congestive Heart Failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days from time of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with advanced cancer to see if it is safe and effective.

Who is the study for?

This trial is for patients with metastatic cancer. Specific eligibility criteria are not provided, but typically participants would need to be in good health aside from their cancer and have a life expectancy that allows them to complete the study.

What is being tested?

The study is testing [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair. It's a Phase I trial, which means it's the first time these treatments are being tested in humans to check safety and how well they work.

What are the potential side effects?

Since this is a Phase I trial, side effects are unknown at this stage. The purpose of the study includes determining what side effects may occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have a confirmed cancer with a visible tumor or enlarged lymph node.

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My scans show at least one cancer spot that stands out clearly.

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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 cancer has worsened after treatment as shown by scans.

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I can stay still for up to an hour.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on warfarin for blood thinning.

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I have severe heart failure.

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I have not had serious bleeding in the last two weeks.

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My lung cancer has spread to other parts of my body.

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I have an ongoing infection that hasn't improved with treatment.

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I haven't had major surgery in the last 28 days and don't plan any in the next 6 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,810 Previous Clinical Trials

8,159,593 Total Patients Enrolled

University of California, DavisLead Sponsor

938 Previous Clinical Trials

4,729,709 Total Patients Enrolled

Julie L SutcliffePrincipal InvestigatorUniversity of California, Davis

1 Previous Clinical Trials

30 Total Patients Enrolled

~27 spots leftby Mar 2027

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