Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Julie Sutcliffe (ucdavis)

Description

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).

Official Title

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

Details

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.

Keywords

Metastatic Pancreatic Cancer Locally Advanced Pancreatic Adenocarcinoma integrin PET theranostic Pancreatic Neoplasms [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. [177Lu]Lu DOTA-ABM-5G dose escalation therapy study

Eligibility

You can join if…

Open to people ages 18 years and up

[68Ga]Ga DOTA-5G PET/CT Inclusion Criteria:

  1. Ability to understand and willingness to sign a written informed consent document.
  2. Age 18 or more years
  3. 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)
  4. 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
  5. Eastern Cooperative Oncology Group Performance Status ≤ 2
  6. 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.
  7. Hematologic parameters defined as:
  8. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
  9. Platelet count ≥ 100,000/mm3
  10. Hemoglobin ≥ 8 g/dL
  11. Blood chemistry levels defined as:
  12. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  13. Total bilirubin ≤ 2 times ULN
  14. Creatinine ≤ 2 times ULN
  15. Anticipated life expectancy ≥ 3 months
  16. . Able to remain motionless for up to 30-60 minutes per scan

[177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria:

  1. Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
  2. The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal lung or liver)

You CAN'T join if...

  • [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

Location

  • University of California Davis accepting new patients
    Sacramento California 95817 United States

Lead Scientist at University of California Health

  • Julie Sutcliffe (ucdavis)
    Professor, Hematology and Oncology. Authored (or co-authored) 56 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT04665947
Phase
Phase 1
Study Type
Interventional
Last Updated