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

BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer Resectable; Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection; Pancreatic Cancer Borderline
• Intervention / Treatment: Combination product: ASP-1929 photoimmunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Roxanne Wood, MPH; Phone Number: 401-863-3000; Email: roxanne_wood@brown.edu
• Study Contact Backup: Name: BrUOG; Email: BrUOG@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903/02906
      • Rhode Island and the Miriam Hospitals (Brown University Health)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ASP-1929 PIT; 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

Combination product: ASP-1929 photoimmunotherapy; 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.; Other Names: cetuximab sarotalocan; RM-1929; ASP-1929 PIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: The Miriam Hospital; Rhode Island Hospital; Rakuten Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2033

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: ASP-1929; photoimmunotherapy; RM-1929; EGFR targeting antibody; laser-light activable dye IR700; IRDye 700DX; cetuximab sarotalocan
• Other Study ID Numbers: BrUOG 438; 1929-IIR-0016 (Other Identifier: Rakuten)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No