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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced pancreatic cancer, specifically those whose cancer cannot be surgically removed (locally advanced) or has spread to other parts of the body (metastatic). The treatment involves two components: a special imaging agent called [68Ga]Ga DOTA-5G, which helps doctors see the cancer in scans, and [177Lu]Lu DOTA-ABM-5G, which is a targeted radiation therapy. The main goals of this study are to assess how safe these treatments are and whether they can effectively help patients with pancreatic cancer.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with locally advanced or metastatic pancreatic cancer that has shown progression despite previous treatments. They should be able to sign consent forms and have specific health criteria met, such as having a certain level of blood counts and organ function. Participants will undergo scans to evaluate their condition and may receive the new treatment if they qualify. It’s important to know that this trial is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if it’s a suitable option for them.

Gender

ALL

Eligibility 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