Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMD Serono Research & Development Institute, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

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 inclusion criteria could apply

Disqualifiers

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

Trial design

Treatments tested in this trial

  • M9140
  • M9140
  • Bevacizumab
  • Capecitabine
  • 5-fluorouracil (5-FU)
  • Folinic acid

Treatment groups

200 Participants
are divided into 5 treatment groups

Locations

35
Canada
The Ottawa Hospital Cancer Centre Ottawa Canada
University Health Network - Princess Margaret Cancer Centre Toronto Canada
Japan
National Cancer Center Hospital - Dept of Gastroenterology Chūōku Japan
National Cancer Center Hospital East Kashiwa-shi Japan

Sponsors and collaborators

EMD Serono Research & Development Institute, Inc.

Lead sponsor

Merck KGaA, Darmstadt, Germany

Collaborator