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First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer

ConditionsMetastatic Pancreatic CancerLocally Advanced Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

This is a Phase I, first-in-human study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic adenocarcinoma (PDAC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and willingness to sign a written informed consent document.

Age 18 or more years

Confirmed presence of locally advanced, unresectable or metastatic pancreatic adenocarcinoma (other pancreatic malignant histologies are excluded) with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis)

Participant must have documented tumor progression during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment

Disqualifiers

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

Participants with Class 3 or 4 NYHA Congestive Heart Failure

Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)

Pregnant or lactating women

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Drug

    PET imaging using \[68Ga\]Ga DOTA-5G will be used to diagnose patients who are eligible for treatment with the \[177Lu\]Lu DOTA-ABM-5G.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: [177Lu]Lu DOTA-ABM-5G dose escalation therapy studyExperimental treatment 1 intervention
Group B: Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Assessment of \[68Ga\]Ga DOTA-5G PET/CT imaging to detect lesions in patients with locally advanced or metastatic pancreatic cancer

Time frame
2 hours from time of injection
2

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

Frequency of dose-limiting toxicities (DLT) of \[177Lu\]Lu DOTA-ABM-5G at escalating dose levels of \[177Lu\]Lu DOTA-ABM-5G

Time frame
30 days from time of injection

Secondary outcomes

1

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

Assessment of organ dosimetry of \[177Lu\]Lu DOTA-ABM-5G using SPECT/CT imaging at various timepoints

Time frame
7-14 days from time of injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov
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