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

Trial ID: NCT04665947

Interventional - Phase 1 - Active, not recruiting

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).

Conditions

• Metastatic Pancreatic Cancer
• Locally Advanced Pancreatic Adenocarcinoma

Interventions

• [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Eligibility

Inclusion criteria

• \[68Ga\]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:
• 1. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
• 2. Platelet count ≥ 100,000/mm3
• 3. Hemoglobin ≥ 8 g/dL
• 8. Blood chemistry levels defined as:
• 1. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
• 2. Total bilirubin ≤ 2 times ULN
• 3. Creatinine ≤ 2 times ULN
• 9. Anticipated life expectancy ≥ 3 months
• 10. 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)

Exclusion criteria

• \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria:
• 1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
• 2. Participants with Class 3 or 4 NYHA Congestive Heart Failure
• 3. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
• 4. Pregnant or lactating women
• 5. 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
• 6. Has an additional active malignancy requiring therapy within the past 2 years
• 7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• 8. Psychiatric illness/social situations that would interfere with compliance with study requirements
• 9. Previous radiation therapy for the treatment of advanced or metastatic disease
• 10. Cannot undergo PET/CT scanning because of weight limits (350 lbs)
• 11. INR\>1.2; PTT\>5 seconds above UNL

Sponsor

University of California, Davis

Source: ClinicalTrials.gov

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