A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy
Public ClinicalTrials.gov record NCT06528093. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy. Another purpose is to check whether BI 765883 helps people with advanced pancreatic cancer. In this study, BI 765883 is given to humans for the first time. Participants receive either BI 765883 alone or BI 765883 in combination with chemotherapy. Participants can stay in the study as long as they benefit from treatment and can tolerate it. At study visits, doctors collect information on any health problems of the participants and check the severity of participants' cancer.
Study identification
- NCT ID
- NCT06528093
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 15, 2024
- Primary completion
- Mar 18, 2025
- Completion
- Jun 18, 2025
- Last update posted
- Jul 14, 2026
2024 – 2025
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HealthONE | Denver | Colorado | 80218 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Florida Cancer Specialists-Sarasota-61670 | Sarasota | Florida | 34232 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06528093, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06528093 live on ClinicalTrials.gov.