Your session is about to expire
← Back to Search
Virus Therapy
M9466 + Irinotecan (Run-in Cohort) for Solid Tumors
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
* M9466 + Irinotecan Run-in Cohort: 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 (that is \[i.e.\] participants who have exhausted all standard of care (SoC) options according to International Guidelines), and who may derive clinical benefit from the combination treatment with M9466 and irinotecan
* M9466 + FOLFIRI + Bevacizumab Dose Finding Cohorts: 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 that included: Oxaliplatin and a fluoropyrimidine (administration in the adjuvant setting fulfills this criterion if progression occurred within 12 months of the last dose). Prior use of irinotecan is permitted; Either an anti- epidermal growth factor receptor (anti-EGFR) or an anti- Vascular endothelial growth factor (anti-VEGF) agent (not applicable if oxaliplatin was administered in the adjuvant setting); An immune checkpoint inhibitor for participants with known MSI-H status; Cetuximab and encorafenib ± binimetinib, if locally available, for participants with BRAF V600E mutations. Participants may have received maximally 1 previous regimen for the treatment of metastatic disease (with the exception of participants with MSI-H disease or BRAF positive disease who are allowed to have had up to 2 previous lines of treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first treatment of study intervention up to planned assessment at 18.7 months
Awards & highlights
Summary
The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion. Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die. Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from first treatment of study intervention up to planned assessment at 18.7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first treatment of study intervention up to planned assessment at 18.7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Dose Limiting Toxicity (DLT)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs
Secondary study objectives
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Assessed by Investigator
Pharmacokinetic (PK) Plasma Concentration of M9466
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 4
~2680
Fluorouracil (5-FU)
2014
Completed Phase 2
~300
Folinic acid
2012
Completed Phase 3
~1290
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
82 Previous Clinical Trials
30,965 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
440 Previous Clinical Trials
114,915 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
295 Previous Clinical Trials
69,418 Total Patients Enrolled
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger