EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer

Brown University

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection; Pancreatic Cancer Resectable; Pancreatic Cancer Borderline

Treatments: Combination Product: ASP-1929 photoimmunotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07698613

BrUOG 438

1929-IIR-0016 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically confirmed pancreatic adenocarcinoma.

2. Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.

3. Completed neoadjuvant chemotherapy

4. Neoadjuvant radiation is allowed

5. Planned surgical exploration

6. Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.

7. Patients with a history of biliary obstruction must have adequate biliary drainage.

8. 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

9. Age ≥ 18

10. ECOG performance status 0-1

11. For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.

12. Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

1. Patients with distant metastases.
2. Patients with medical co-morbidities that make them not candidates for surgical exploration
3. Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929
4. Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2.
5. History of significant (Grade ≥ 3) cetuximab infusion reactions
6. Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.
7. No uncontrolled intercurrent illness including but not limited to symptomatic CHF, unstable angina, clinically significant severe cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements.
8. Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to PIT illumination.
9. Women who are pregnant or nursing.
10. Patients with concomitant malignancies not expected to cause death within 5 years are eligible.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ASP-1929 PIT

Experimental group

Description:

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

Treatment:

Combination Product: ASP-1929 photoimmunotherapy