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

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

Trial Details

NCT ID
NCT05464030
Phase
PHASE1
Sponsor
EMD Serono Research & Development Institute, Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • M9140
  • Bevacizumab
  • Capecitabine
  • 5-fluorouracil (5-FU)
  • Folinic acid
Locations (sample)
  • Encinitas, California, United States|33.03699,-117.29198
  • Fresno, California, United States|36.74773,-119.77237
  • Providence, Rhode Island, United States|41.82399,-71.41283
  • Dallas, Texas, United States|32.78306,-96.80667
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory …
  • 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

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →