For Healthcare Professionals

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors

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About the study

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. Study details include: Study Duration per participant: Approximately 4 months M9140 is not available through an expanded access program
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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 advanced/metastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated.
  2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than (<) 1
  3. Participants with adequate hematologic, hepatic and renal function as defined in protocol
  4. Other protocol defined inclusion criteria could apply

EXCLUSION CRITERIA

Exclusion Criteria:

  1. 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)
  2. 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)
  3. Participants with diarrhea (liquid stool) or ileus Grade > 1
  4. Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
  5. 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)
  6. Cerebrovascular accident/stroke (< 6 months prior to enrollment)
  7. Other protocol defined exclusion criteria could apply

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 888-275-7376Email iconEmail Study Center

Study’s details


Contition

Colorectal Cancer

Age (in years)

18+

Phase

Phase 1

Participants needed

31

Est. Completion Date

Nov 28, 2023

Treatment type

Interventional


Sponsor

EMD Serono

ClinicalTrials.gov identifier

NCT05464030

Study number

MS202329_0001

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