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New treatment option for Colorectal Cancer
Official title Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
ClinicalTrials.gov ID: NCT05464030
What this study is testing
What is M9140?
M9140 is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as Precemtabart tocentecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 M9140 is not available through an expanded access program
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
- Participants with adequate hematologic, hepatic and renal function as defined in protocol
- Other protocol defined could apply
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...
- Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are...
- 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...
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] \>= II) or a coronary revascularization procedure...
- Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
See the full eligibility criteria
- Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
- Participants with adequate hematologic, hepatic and renal function as defined in protocol
- Other protocol defined could apply
- 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...
- 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...
- 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
- 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...
- Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
- Other protocol defined exclusion criteria could apply
The study team makes the final eligibility decision.
Where it's taking place
- Encinitas, California, United States
- Fresno, California, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Ottawa, Canada
- Toronto, Canada
- Chūōku, Japan
- Kashiwa-shi, Japan
- Kitaadachi-gun, Japan
- Kōtoku, Japan
- Nagoya, Japan
- Osakasayama-shi, Japan
- Sunto-gun, Japan
- Yokohama, Japan
- Daegu, South Korea
- Goyang-si, South Korea
- Seongnam, South Korea
- Seoul, South Korea
+ 6 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encinitas, California, United States; Fresno, California, United States; Providence, Rhode Island, United States; Dallas, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States and 20 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.