A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

Summary

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

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  M9140

  M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Part 1 of the study.

• Drug
  M9140

  M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.

• Drug
  Bevacizumab

  Bevacizumab will be administered intravenously as per standard of care.

• Drug
  Capecitabine

  Capecitabine will be administered orally as per standard of care.

• Drug
  5-fluorouracil (5-FU)

  5-FU will be administered intravenously as per standard of care.

• Drug
  Folinic acid

  Folinic acid will be administered intravenously as per standard of care.

Locations (35)