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

7. juli 2026 oppdatert av: Brown University

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
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.
Andre navn:
  • cetuximab sarotalocan
  • RM-1929
  • ASP-1929 PIT

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of treatment related toxicities grade ≥3
Tidsramme: From start of treatment to 28 days post surgery
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
Tidsramme: From start of treatment to 6 months post surgery.
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mars 2029

Studiet fullført (Antatt)

1. september 2033

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • BrUOG 438
  • 1929-IIR-0016 (Annen identifikator: Rakuten)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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