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Anti-tumor Antibody-drug Conjugate

M9140 for Colorectal Cancer

Phase 1
Recruiting
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: up to 4 months; part 2: up to 8 months
Awards & highlights

Study Summary

This trial is testing a new drug, M9140, for safety and preliminary effectiveness in people with advanced solid tumors. The trial will last approximately 4 months per person, and M9140 is not yet available outside of the trial.

Who is the study for?
This trial is for adults with advanced colorectal cancer who've had no luck or bad reactions to standard treatments. They must be in good physical shape (ECOG PS < 1), and have their major organs working well. It's not for those with recent other cancers, brain metastases causing symptoms, chronic bowel inflammation, serious heart issues within the past 6 months, or certain severe digestive problems.Check my eligibility
What is being tested?
The study tests M9140, a new drug aimed at solid tumors like colorectal cancer. Participants will also receive Bevacizumab and Capecitabine. The trial has two parts: first finding the right dose of M9140 (Part 1) and then seeing how well it works at that dose (Part 2).See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer drugs such as fatigue, nausea, diarrhea, risk of infection due to low blood counts; specific side effects related to M9140 are being studied since this is its first use in humans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: up to 4 months; part 2: up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: up to 4 months; part 2: up to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Part 1: Recommended Dose Expansion (RDE) of M9140
Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
+3 more
Secondary outcome measures
Part 2A: Number of Participants with Symptomatic Adverse Events (AEs)
Part 2A: Overall Survival
Parts 1 and 2: Levels of Titers of Anti-Drug Antibody (ADA) Against M9140
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2C: M9140 + Bevacizumab +/-CapecitabineExperimental Treatment3 Interventions
Group II: Part 2B: M9140Experimental Treatment1 Intervention
Group III: Part 2A: M9140Experimental Treatment1 Intervention
Group IV: Part 1: M9140Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,476 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,680 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
288 Previous Clinical Trials
68,795 Total Patients Enrolled

Media Library

M9140 (Anti-tumor Antibody-drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05464030 — Phase 1
Colorectal Cancer Research Study Groups: Part 2C: M9140 + Bevacizumab +/-Capecitabine, Part 1: M9140, Part 2A: M9140, Part 2B: M9140
Colorectal Cancer Clinical Trial 2023: M9140 Highlights & Side Effects. Trial Name: NCT05464030 — Phase 1
M9140 (Anti-tumor Antibody-drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464030 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being accepted into this experiment at the present?

"This research endeavour is recruiting participants, as evidenced by its listing on clinicaltrials.gov which was initially created on August 4th 2022 and most recently updated November 3rd of the same year."

Answered by AI

How many participants are currently enrolled in this research?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, initially posted on August 4th 2022 and most recently updated November 3rd 2022 is actively enrolling individuals in need of care. Two medical centres are recruiting a total of 30 participants for the study."

Answered by AI

Has M9140 been officially certified by the FDA?

"Our team at Power has assigned M9140 a score of 1 on the safety scale as this is an early phase trial which offers limited information regarding efficacy and danger."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
MD Anderson Cancer Center - Oncology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors
2022. "Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05464030.
All > Colorectal Cancer Austin
~94 spots leftby Feb 2026
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