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A First-in-human Open Label Phase Ia/Ib, Multicenter/Multiregional, Dose Escalation Study of BI 765883 Administered Intravenously as Monotherapy and in Combination With Gemcitabine and Nab-paclitaxel in Unselected Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) or Patients With PDAC Who Have Relapsed Within 6 Months After Post-surgery Adjuvant Therapy

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Trial Profile

A First-in-human Open Label Phase Ia/Ib, Multicenter/Multiregional, Dose Escalation Study of BI 765883 Administered Intravenously as Monotherapy and in Combination With Gemcitabine and Nab-paclitaxel in Unselected Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) or Patients With PDAC Who Have Relapsed Within 6 Months After Post-surgery Adjuvant Therapy

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 16 May 2025

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At a glance

  • Drugs BI 765883 (Primary) ; Gemcitabine (Primary) ; Paclitaxel (Primary)
  • Indications Adenocarcinoma; Pancreatic ductal carcinoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 02 Apr 2025 Planned primary completion date changed from 16 Nov 2026 to 15 Apr 2027.
  • 05 Mar 2025 Planned End Date changed from 24 Nov 2028 to 24 Nov 2027.
  • 05 Mar 2025 Planned End Date changed from 27 Jan 2028 to 24 Nov 2028.

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