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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2024
  • participants needed
    30
  • sponsor
    University of California, Davis
Updated on 13 May 2022

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).

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.

Details
Condition Metastatic Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma
Treatment [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Clinical Study IdentifierNCT04665947
SponsorUniversity of California, Davis
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

[68Ga]Ga DOTA-5G PET/CT Inclusion Criteria
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
Eastern Cooperative Oncology Group Performance Status ≤ 2
Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to [68Ga]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline
Hematologic parameters defined as
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 8 g/dL
Blood chemistry levels defined as
AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
Total bilirubin ≤ 2 times ULN
Creatinine ≤ 2 times ULN
Anticipated life expectancy ≥ 3 months
Able to remain motionless for up to 30-60 minutes per scan
[177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria
Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal lung or liver)

Exclusion Criteria

[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G therapy Exclusion Criteria
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
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
Has an additional active malignancy requiring therapy within the past 2 years
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Psychiatric illness/social situations that would interfere with compliance with study requirements
Previous radiation therapy for the treatment of advanced or metastatic disease
Cannot undergo PET/CT scanning because of weight limits (350 lbs)
INR>1.2; PTT>5 seconds above UNL
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