What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, including radioligand therapies like Lutetium-177 (177Lu) and chemotherapies such as gemcitabine combined with nab-paclitaxel, have notable side effects. Radioligand therapies can lead to nephrotoxicity, myelodysplastic syndrome, and acute myeloid leukemia, particularly in heavily pretreated patients. Chemotherapy regimens often result in neutropenia, fatigue, neuropathy, and gastrointestinal issues like nausea and diarrhea. These side effects are important considerations for patients and healthcare providers when planning treatment.

What prior FDA approvals exist?

The FDA has approved several radiopharmaceutical therapies for various cancers, but specific approvals for pancreatic cancer using Gallium-68 for diagnostic imaging and Lutetium-177 for targeted radiotherapy are not well-documented. However, Lutetium-177 has been approved for treating somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which share some similarities with pancreatic cancer in terms of treatment approach. The approved treatment, Lutetium Lu 177 Dotatate, involves targeted radiotherapy similar to the [177Lu]Lu DOTA-ABM-5G being studied. This approval highlights the potential for Lutetium-177-based therapies in treating cancers with specific receptor targets.

What other types of research exist?

Promising alternatives include [(67)Ga/(177)Lu]-DOTA-PESIN, which has shown high and specific tumor uptake and good retention in GRP receptor-expressing tumors, and (66)Ga-DOTA-E-[c(RGDfK)]2, which has demonstrated potential as a theranostic radiopharmaceutical with high specific activity and favorable biodistribution in preclinical studies.

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Radioisotope Therapy

DOTA-5G Pair for Pancreatic 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

The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal lung or liver)

Eastern Cooperative Oncology Group Performance Status ≤ 2

Must not have

Major surgery within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks

Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-14 days from time of injection

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new two-part treatment for advanced pancreatic cancer. The first part helps doctors see the cancer in scans, and the second part delivers targeted radiation to treat it.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic pancreatic cancer who have finished chemotherapy at least two weeks prior and resolved any significant side effects. They must be able to lie still for scans, not have other active cancers needing treatment, no major surgery recently or coming up soon, and no severe infections or heart failure.

What is being tested?

The study tests a new theranostic pair [68Ga]Ga DOTA-5G (for imaging) and [177Lu]Lu DOTA-ABM-5G (for therapy) in patients with pancreatic cancer. It aims to assess the safety and effectiveness of these agents in detecting and treating the disease.

What are the potential side effects?

As this is a first-in-human study, specific side effects are unknown but may include reactions related to radiation exposure from the imaging agent and therapeutic compound.

Eligibility Criteria

Inclusion Criteria

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

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My scans show at least one cancer spot that's clearly visible.

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

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I finished my last chemotherapy over 2 weeks ago and any side effects have mostly gone.

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My pancreatic cancer is advanced and cannot be removed by surgery.

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I am 18 years old or older.

Exclusion Criteria

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

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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.

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I am taking blood thinners other than aspirin.

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I have severe heart failure.

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I do not have any ongoing serious infections needing treatment.

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I have another cancer that needed treatment in the last 2 years.

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I have had radiation therapy for advanced or metastatic disease.

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I haven't had serious bleeding in the last two weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-14 days from time of injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-14 days from time of injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days from time of injection for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

[177Lu]Lu DOTA-ABM-5G dose escalation therapy

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

Secondary study objectives

Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: [177Lu]Lu DOTA-ABM-5G dose escalation 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. Escalating doses of 25-200 mCi of \[177Lu\]Lu DOTA-ABM-5G will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.

Group II: Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G 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.10 patients will be enrolled in the dose expansion cohort and recieve the highest dose achieved in the \[177Lu\]Lu DOTA-ABM-5G dose escalation therapy study

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The treatments [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G involve a theranostic approach combining diagnostic imaging and targeted radiotherapy. [68Ga]Ga DOTA-5G is used for PET imaging to identify and localize pancreatic cancer cells by binding to specific receptors on the tumor. Once identified, [177Lu]Lu DOTA-ABM-5G delivers targeted radiotherapy to these cancer cells, minimizing damage to surrounding healthy tissue. This dual approach is crucial for pancreatic cancer patients as it allows for precise tumor detection and effective treatment, potentially improving outcomes and reducing side effects compared to conventional therapies.