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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Criteria

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