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| ID | Type | Description | Link |
|---|---|---|---|
| 1929-IIR-0016 | Other Identifier | Rakuten |
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| Name | Class |
|---|---|
| Rakuten Medical, Inc. | INDUSTRY |
| Rhode Island Hospital | OTHER |
| The Miriam Hospital | OTHER |
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This is an open label phase II study to determine the safety and preliminary efficacy of photoimmunotherapy (PIT) for patients with locally advanced and borderline resectable pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP-1929 PIT | Experimental | Approximately 24 hours prior to surgery patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic. ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700. The following day patients will undergo standard surgical exploration. Patients found to be inoperable will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy. Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system. [Patients who are resectable will undergo resection of their pancreatic cancer and will not receive the laser and their tumor will subsequently be evaluated for EGFR receptor saturation.] Part 1: There will be a 10-patient safety run-in Part 2: If Part 1 is acceptable, an additional 20 patients will receive PIT to determine preliminary efficacy in a total of 30 patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP-1929 photoimmunotherapy | Combination Product | Approximately 24 hours prior to surgery, patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic. ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700 (IRDye 700DX). The following day patients will undergo standard surgical exploration. Those patients found to be inoperable on surgical exploration will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy. Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment related toxicities grade ≥3 | Part 1 | Safert: The primary endpoint is grade 3 or higher ASP-1929 photoimmunotherapy treatment related toxicity within 28 days of surgery. | From start of treatment to 28 days post surgery |
| Number of Participants Reaching 6 Months Progression Free Survival | Part 2 (expansion cohort for efficacy): The primary endpoint of this cohort is 6-month progression free survival. RECIST version 1.1 will be used to assess for response/progression | From start of treatment to 6 months post surgery. |
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Inclusion Criteria:
Pathologically confirmed pancreatic adenocarcinoma.
Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.
Completed neoadjuvant chemotherapy
Neoadjuvant radiation is allowed
Planned surgical exploration
Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.
Patients with a history of biliary obstruction must have adequate biliary drainage.
Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function:
Platelet Count ≥ 75,000/mm3. Hemoglobin ≥ 8.0 g/dL [NOTE: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible] Absolute neutrophil count ≥ 1,000/mm3. [Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1] Alanine aminotransferase (ALT) ≤ 3×ULN Aspartate aminotransferase (AST) ≤ 3×ULN Total Bilirubin ≤ 1.5×ULN or < 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) Creatinine ≤ 3×ULN
Age ≥ 18
ECOG performance status 0-1
For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roxanne Wood, MPH | Contact | 401-863-3000 | roxanne_wood@brown.edu | |
| BrUOG | Contact | BrUOG@brown.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island and the Miriam Hospitals (Brown University Health) | Providence | Rhode Island | 02903/02906 | United States |
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