First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
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
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
Treatments tested in this trial
- [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
1University of California Davis95817, SacramentoCalifornia, United States
Sponsors and collaborators
University of California, Davis
Lead sponsor
Source ClinicalTrials.gov