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Virus Therapy

M9466 + Chemotherapy for Colorectal Cancer

Phase 1
Waitlist Available
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
Eastern Cooperative Oncology Group performance status (ECOG PS) less than or equal to (<=) 1
Participants with locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
Must not have
Participant has a history of malignancy within 3 years before the date of enrollment
Participant with known polymorphisms in UGT1A1, DPYD or other enzymes known to predict for increased toxicity from irinotecan or 5 fluorouracil (5-FU) should be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial aims to test the safety and effectiveness of M9466 in combination with certain chemotherapy drugs for colorectal cancer. Participants will be monitored for a period of time after receiving the treatment to determine the

Who is the study for?
This trial is for individuals with advanced colorectal cancer or solid tumors. Participants must be able to receive the chemotherapy combination FOLFIRI and Bevacizumab. The study aims to find the highest dose of M9466 that's safe when given with these drugs, without causing severe side effects.
What is being tested?
The trial tests a new drug, M9466, combined with a chemo regimen (FOLFIRI) and Bevacizumab in patients with colorectal cancer. It seeks to determine safety, tolerability, and preliminary effectiveness of this combination therapy.
What are the potential side effects?
Possible side effects include those typical of chemotherapy such as nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems; plus any unknown risks from the new drug M9466.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer is advanced and hasn't responded to standard treatments.
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My colorectal cancer is advanced and didn't respond well to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was diagnosed with cancer within the last 3 years.
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I do not have genetic variations that increase risk of side effects from irinotecan or 5-FU.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: M9466 + Irinotecan (Run-in Cohort)Experimental Treatment2 Interventions
Group II: M9466 + FOLFIRI (folinic acid, fluorouracil, irinotecan) + Bevacizumab (Dose Finding Cohorts)Experimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 3
~2580
Fluorouracil (5-FU)
2014
Completed Phase 2
~300
Folinic acid
2012
Completed Phase 3
~1290
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
82 Previous Clinical Trials
22,572 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
440 Previous Clinical Trials
114,520 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
295 Previous Clinical Trials
60,926 Total Patients Enrolled
~36 spots leftby Apr 2026
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