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Phase 1b/2 Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC)
EU CTIS ID: 2024-517819-74-00
What this study is testing
To determine clinical activity in terms of Objective Response (OR) of M9140 monotherapy q3w.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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 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).
- Participants with diarrhea (liquid stool) or ileus Grade > 1.
- 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).
- Cerebrovascular accident/stroke (< 6 months prior to enrollment).
See the full eligibility criteria
- 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.
- 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 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).
- Participants with diarrhea (liquid stool) or ileus Grade > 1.
- 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).
- Cerebrovascular accident/stroke (< 6 months prior to enrollment).
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Australia
- United States
- China
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Australia; United States; China; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.