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Finding the right dose of BI 765883 for advanced pancreatic cancer treatment

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 After Post-surgery Adjuvant Therapy

Phase 1 Interventional Boehringer Ingelheim · NCT06528093

This study is testing the best dose of a new drug called BI 765883 for adults with advanced pancreatic cancer who haven't had success with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment68 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionschemotherapy
Locations18 sites (Denver, Colorado and 17 other locations)
Trial IDNCT06528093 on ClinicalTrials.gov

What this trial studies

This study aims to determine the maximum tolerated dose of BI 765883 in adults with advanced pancreatic ductal adenocarcinoma, either as a standalone treatment or in combination with chemotherapy. Participants will receive either BI 765883 alone or alongside gemcitabine or nab-paclitaxel, with ongoing assessments of their health and cancer severity. The study is particularly focused on patients who have not responded to previous treatments or have no existing treatment options. This is the first time BI 765883 is being administered to humans.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed advanced pancreatic ductal adenocarcinoma and a life expectancy of at least three months.

Not a fit: Patients with early-stage pancreatic cancer or those who have not been previously treated may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced pancreatic cancer who have limited alternatives.

How similar studies have performed: Other studies have shown promise in using novel agents for advanced pancreatic cancer, but this specific approach with BI 765883 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
2. Of legal adult age (according to local legislation) at screening
3. Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
4. Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
6. Life expectancy ≥3 months in the opinion of the investigator
7. Archived tumor tissue from a tissue core biopsy (e.g. paraffin-embedded formalin-fixed tissue blocks), OR fresh tumor tissue available for retrospective biomarker analysis; in both cases, a minimum of at least two core needle biopsies (18 gauge or greater) is required. Only non-significant risk procedures per the investigator's judgment will be used to obtain any biopsies specified in this study in cases where a fresh tumor biopsy is required.
8. Patients with at least 1 target lesion that can be accurately measured per RECIST version 1.1 Further inclusion criteria apply.

Exclusion Criteria:

1. Previous exposure to trial drug (BI 765883)
2. Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts)
3. Known hypersensitivity to the study medications or their excipients (including gemcitabine and nab-paclitaxel)
4. Any contraindications to gemcitabine or nab-paclitaxel according to the current approved local labels (combination therapy)
5. Currently enrolled in another investigational device or drug trial, or less than 28 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s)
6. Any serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease, active ulcers (gastrointestinal tract, skin), inflammatory bowel disease or bowel infection, or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the Investigator, would make the patient inappropriate for entry into the trial.
7. Prior radiotherapy or systemic therapy within 14 days prior to treatment start
8. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator Further exclusion criteria apply.

Where this trial is running

Denver, Colorado and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Ductal Adenocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.