Pancreatic Ductal AdenocarcinomaPhase 1NCT06528093
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
A Phase 1 study testing BI 765883, Gemcitabine and Nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Boehringer Ingelheim at 17 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- BI 765883, Gemcitabine and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 16 Oct 2024to 19 Jun 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Of legal adult age (according to local legislation) at screening
- 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.
- Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Life expectancy ≥3 months in the opinion of the investigator
- 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.
- Patients with at least 1 target lesion that can be accurately measured per RECIST version 1.1 Further inclusion criteria apply.
Who cannot join
- Previous exposure to trial drug (BI 765883)
- Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts)
- Known hypersensitivity to the study medications or their excipients (including gemcitabine and nab-paclitaxel)
- Any contraindications to gemcitabine or nab-paclitaxel according to the current approved local labels (combination therapy)
- 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)
- 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.
- Prior radiotherapy or systemic therapy within 14 days prior to treatment start
- 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.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United States5 sites
HealthONE
Denver, Colorado, 80218
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
SCRI Oncology Partners
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida, 34232
France3 sites
CTR Leon Berard
Lyon, 69373
CTR Eugène Marquis
Rennes, 35042
Institut Gustave Roussy
Villejuif, 94805
Germany3 sites
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
Klinikum der Universität München AÖR
München, 81377
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
Japan2 sites
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Spain2 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario Ramon Y Cajal
Madrid, 28034
About this study
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
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- BI 765883, Gemcitabine, Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 765883Drug
Participants received BI 765883 at doses of 0.4 mg/kg or 1.3 mg/kg, administered intravenously.
GemcitabineDrug
Participants received gemcitabine at a dose of 1000 mg/m², administered intravenously
Nab-paclitaxelDrug
Participants received Nab-paclitaxel at a dose of 125 mg/m², administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| BI 765883 0.4 mg/kg, monotherapy | Experimental | Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle. Receives: Drug: BI 765883 |
| BI 765883 1.3 mg/kg, monotherapy | Experimental | Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle. Receives: Drug: BI 765883 |
| BI 765883 0.4 mg/kg + chemotherapy | Experimental | Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle. Receives: Drug: BI 765883; Drug: Gemcitabine; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose-Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period for the Determination of the Maximum Tolerated Dose (MTD)
All Dose-Limiting Toxicities (DLTs) were agreed upon by the Dose-Escalation Committee (DEC) after review of the data from each cohort. Only Dose-Limiting Toxicities (DLTs) occurring in the first 2 cycles were considered necessary for dose-escalation decisions made by the Dose-Escalation Committee (DEC). Dose-Limiting Toxicities (DLTs) observed during the Maximum Tolerated Dose (MTD) evaluation period were considered for Maximum Tolerated Dose (MTD) determination.
The MTD evaluation period was defined as the first two treatment cycles; i.e. from Cycle 1 Day 1 (C1D1) up to and including the day before C3D1, or to the end of the REP in case of discontinuation before the start of C3.
Measured: The MTD evaluation period corresponds to the first two treatment cycles (28 days), with extension up to 35 days in cases of early discontinuation, based on the residual effect period.
Secondary outcomes (5)
Best Overall Response as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Objective Response is defined as the best overall response of complete response (CR) or partial response (PR), recorded from the start of the study treatment until the earliest of disease progression, death, or last evaluable tumor assessment, and before start of subsequent anti-cancer therapy.
Measured: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Disease Control as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Disease control (DC) was defined as complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) from the start of treatment until the earliest of progressive disease (PD), death, or the last evaluable tumor assessment and before the start of subsequent anti-cancer therapy.
Measured: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Objective Response (OR) as Assessed by the Investigator Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Objective response (OR) is defined as the best overall response of complete response (CR) or partial response (PR), recorded from the start of the study treatment until the earliest of progressive disease (PD), death, or the last evaluable tumor assessment, and before the start of subsequent anti-cancer therapy.
Measured: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Maximum Measured Concentration of BI 765883 in Serum (Cmax)
The maximum measured concentration of the BI 765883 in serum is reported.
Measured: Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.
Area Under the Concentration-Time Curve of BI 765883 From Time 0 to 336 Hours (AUC₀-336)
The area under the serum concentration time curve of BI 765883 from time 0 to 336 hours is reported.
Measured: Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start16 Oct 2024
- Primary completion19 Mar 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528093
- Sponsor's protocol ID
- 1505-0001
- Other IDs
- 2023-508998-85-00, U1111-1300-7624, 2023
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2024
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06528093
- Acronym / sponsor ID
- 1505-0001
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 765883 0.4 mg/kg, monotherapy | Experimental | Drug: BI 765883Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle. |
| BI 765883 1.3 mg/kg, monotherapy | Experimental | Drug: BI 765883Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle. |
| BI 765883 0.4 mg/kg + chemotherapy | Experimental | Drug: BI 765883, Drug: Gemcitabine, Drug: Nab-paclitaxelParticipants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Of legal adult age (according to local legislation) at screening
- 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.
- Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Key exclusion criteria (8 listed)
- Previous exposure to trial drug (BI 765883)
- Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts)
- Known hypersensitivity to the study medications or their excipients (including gemcitabine and nab-paclitaxel)
- Any contraindications to gemcitabine or nab-paclitaxel according to the current approved local labels (combination therapy)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 765883Participants received BI 765883 at doses of 0.4 mg/kg or 1.3 mg/kg, administered intravenously. | Drug | BI 765883 0.4 mg/kg + chemotherapy, BI 765883 0.4 mg/kg, monotherapy, BI 765883 1.3 mg/kg, monotherapy |
| GemcitabineParticipants received gemcitabine at a dose of 1000 mg/m², administered intravenously | Drug | BI 765883 0.4 mg/kg + chemotherapy |
| Nab-paclitaxelParticipants received Nab-paclitaxel at a dose of 125 mg/m², administered intravenously | Drug | BI 765883 0.4 mg/kg + chemotherapy |
Primary outcome
Occurrence of Dose-Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period for the Determination of the Maximum Tolerated Dose (MTD)
Time frame: The MTD evaluation period corresponds to the first two treatment cycles (28 days), with extension up to 35 days in cases of early discontinuation, based on the residual effect period.
All Dose-Limiting Toxicities (DLTs) were agreed upon by the Dose-Escalation Committee (DEC) after review of the data from each cohort. Only Dose-Limiting Toxicities (DLTs) occurring in the first 2 cycles were considered necessary for dose-escalation decisions made by the Dose-Escalation Committee (DEC). Dose-Limiting Toxicities (DLTs) observed during the Maximum Tolerated Dose (MTD) evaluation period were considered for Maximum Tolerated Dose (MTD) determination. The MTD evaluation period was defined as the first two treatment cycles; i.e. from Cycle 1 Day 1 (C1D1) up to and including the day before C3D1, or to the end of the REP in case of discontinuation before the start of C3.
5 secondary outcomes
Best Overall Response as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Disease Control as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Objective Response (OR) as Assessed by the Investigator Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Maximum Measured Concentration of BI 765883 in Serum (Cmax)
Time frame: Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.
Area Under the Concentration-Time Curve of BI 765883 From Time 0 to 336 Hours (AUC₀-336)
Time frame: Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 765883, Gemcitabine and Nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Boehringer Ingelheim at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, France, Germany, Belgium, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose-Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period for the Determination of the Maximum Tolerated Dose (MTD) (time frame: The MTD evaluation period corresponds to the first two treatment cycles (28 days), with extension up to 35 days in cases of early discontinuation, based on the residual effect period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.