Taking peoplePhase 1/2
Tests M9140 in adults with advanced pancreatic cancer
Tests M9140, an antibody-drug treatment, in adults with advanced pancreatic cancer.
Key facts
- Who runs it
- Merck Healthcare KGaA
- Where
- Berlin, Bochum, Dresden, Frankfurt am Main, Leipzig, and Mainz, GermanySee the 6 sitesAlso in 4 other countries, 29 sites
- Trial code
- EU 2024-517819-74-00
- NCT06710132
- Registry title
- Phase 1b/2 Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 26 people, planned
- Started
- 2 Jun 2025
- Planned end
- 10 Sept 2026
- Type of study
- Interventional
- Record updated
- 28 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic pancreatic ductal adenocarcinoma whose cancer got worse after earlier treatment and whose tumor has high CEACAM5.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Advanced or metastatic pancreatic ductal adenocarcinoma, confirmed by tissue or cell tests, with at least 1 lesion that can be measured (RECIST v1.1).
- Earlier treatment
- Must have had at least 1 and no more than 2 earlier lines of treatment for advanced or metastatic disease, and the cancer must have got worse on treatment.
- Biomarker or test result
- Tumor must show high CEACAM5 expression on an IHC test.
Main reasons for not taking part
- Another cancer in the last 3 years (a few exceptions apply)
- Known brain metastases, unless treated and stable for at least 4 weeks with no related symptoms
- Diarrhea or ileus above Grade 1
- Active chronic inflammatory bowel disease or bowel obstruction
- Serious heart problems within 180 days, or stroke less than 6 months ago
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Participants are capable of signing informed consent as defined in protocol
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1
- Participants with adequate hematologic, hepatic and renal function as defined in protocol
- Participant must have at least 1 lesion that is measurable using RECIST v1.1
- Participants with histologically or cytologically confirmed advanced or metastatic PDAC, who were intolerant/refractory to or progressed after systemic therapies for the advanced metastatic stage
- Participants must have received and progressed (according to RECIST v1.1) on at least one 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2
- All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5 high expressing tumors will be eligible
Who cannot take part
- Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
- Cerebrovascular accident/stroke (< 6 months prior to enrollment)
- Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor’s Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
- Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease, intestinal perforation) and/or bowel obstruction
- Cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] ≥ II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms)
- Participants with diarrhea (liquid stool) or ileus Grade > 1
Where in Germany
Also in 4 other countries, 29 sites
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- Katholisches Klinikum Bochum gGmbHBochum, GermanyNot yet recruiting
- Technische Universitaet DresdenDresden, GermanyNot yet recruiting
- Krankenhaus Nordwest GmbHFrankfurt am Main, GermanyNot yet recruiting
- Universitaet LeipzigLeipzig, GermanyNot yet recruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyNot yet recruiting
About the trial
What the trial wants to find out
To determine clinical activity in terms of Objective Response (OR) of M9140 monotherapy q3w.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate Precemtabart Tocentecan (M9140) in Participants With Advanced Pancreatic Cancer (Substudy PDAC)
- Plain-language title
- Tests M9140 in adults with advanced pancreatic cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 September 2026