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

Lab values

• \[68Ga\]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

• \[68Ga\]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)