Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical ResectionPhase 1/2NCT07698613
EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
A Phase 1/2 study testing ASP-1929 photoimmunotherapy in people with Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection and Pancreatic Cancer Borderline, run by Brown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection, Pancreatic Cancer Borderline, Pancreatic Cancer Resectable
- What is being tested?
- ASP-1929 photoimmunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2033
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patients with distant metastases.
- Patients with medical co-morbidities that make them not candidates for surgical exploration
- Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929
- 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.
- History of significant (Grade ≥ 3) cetuximab infusion reactions
- Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.
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- 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.
- 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.
- Women who are pregnant or nursing.
- Patients with concomitant malignancies not expected to cause death within 5 years are eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BrUOG contact
United States1 site
Rhode Island and the Miriam Hospitals (Brown University Health)
Providence, Rhode Island, 02903/02906
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection, Pancreatic Cancer Borderline, Pancreatic Cancer Resectable
- Being tested
- ASP-1929 photoimmunotherapy
- Keywords
- ASP-1929, photoimmunotherapy, EGFR targeting antibody, laser-light activable dye IR700, IRDye 700DX, RM-1929, cetuximab sarotalocan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP-1929 photoimmunotherapyCombination product
Also called RM-1929, ASP-1929 PIT, cetuximab sarotalocan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: ASP-1929 photoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From start of treatment to 6 months post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rakuten Medical, Inc., Rhode Island Hospital, The Miriam Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698613
- Sponsor's protocol ID
- BrUOG 438
- Other IDs
- 1929-IIR-0016
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No