Phase 1b/2 Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC)
Key facts
- Where
- Badalona, Barcelona, L'Hospitalet de Llobregat, Madrid és Pozuelo de Alarcón, SpanyolországSee the 9 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Institut Catala d'OncologiaBadalona, SpanyolországToborzás még nem indult
- Hospital Clinic de BarcelonaBarcelona, SpanyolországToborzás még nem indult
- Hospital HM Nou DelfosBarcelona, SpanyolországToborzás még nem indult
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországToborzás még nem indult
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországToborzás még nem indult
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario HM SanchinarroMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario Ramón y CajalMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpanyolországToborzás még nem indult
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?
Trial details
- Who runs it
- Merck Healthcare KGaA
- Trial code
- EU 2024-517819-74-00
- Record updated
- 2026. szeptember 28.
- Original description
To determine clinical activity in terms of Objective Response (OR) of M9140 monotherapy q3w.Read full original descriptionShow less
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)
To determine clinical activity in terms of Objective Response (OR) of M9140 monotherapy q3w.
Inclusion: 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.
Exclusion: 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.