First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
Summary
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).
Detailed description
This is a Phase I, first-in-human study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G /\[177Lu\]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). PET imaging using \[68Ga\]Ga DOTA-5G will be used to diagnose patients who are eligible for the \[177Lu\]Lu DOTA-ABM-5G. The overall purpose of this study is to identify the dose limiting toxicity (DLT) and recommended phase 2 dose (RP2D) of \[177Lu\]Lu DOTA-ABM-5G. A 3+3 study design in is proposed to identify the RP2D of \[177Lu\]Lu DOTA-ABM-5G. An expansion group will receive the RP2D in order to obtain initial estimates of response and additional information on safety of \[177Lu\]Lu DOTA-ABM-5G. The hypotheses of this phase I study are that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with locally advanced or metastatic pancreas cancer b) the theranostic pair \[68Ga\]Ga DOTA-5G/ \[177Lu\]Lu DOTA-ABM-5G will be safe and well tolerated c) we will be able to identify a Recommended Phase 2 Dose (RP2D) for \[177Lu\]Lu DOTA-ABM-5G therapy to be used in subsequent Phase II trials.
Arms & interventions
- Drug[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
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.
Outcome measures
Primary
[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
[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
Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G
Time frame: 7-14 days from time of injection
Eligibility criteria
Study locations (1)
University of California Davis
Sacramento, California, 95817