Your session is about to expire
← Back to Search
Immune Checkpoint Inhibitor
M1774 Combination Therapy for Solid Tumors
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 baseline up to 18 months
Awards & highlights
Study Summary
This trial is testing the safety and tolerability of M1774 when given with either Drug A or Drug B to people with metastatic or locally advanced unresectable solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that standard treatments haven't helped or aren't suitable. They should be in fairly good physical shape (ECOG 0-1), expected to live at least 3 more months, and have their major organs working well. People can't join if they have other serious health issues, brain cancer spread, recent severe GI bleeding, trouble absorbing food, or had an organ transplant.Check my eligibility
What is being tested?
The study tests M1774 combined with either M4076 or avelumab to find safe doses and see early effects on certain types of prostate and endometrial cancers with specific genetic changes. It's open-label so everyone knows what treatment they're getting; it includes dose finding and testing how the body absorbs the drug.See study design
What are the potential side effects?
Possible side effects include typical reactions to immune therapies like fatigue, skin reactions, inflammation in various organs (like lungs or intestines), as well as potential blood abnormalities. The exact side effects of M1774 are being studied but may be similar.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A1.1: PK Plasma Concentration of M4076 Under Fed and Fasted Conditions
Part A1: Change From Baseline in Pharmacodynamic (PD) Biomarker
Part A1: Number of Participants With Adverse Events (AEs) and Treatment-Related AEs
+9 moreSecondary outcome measures
Part A1 and B1: Number of Participants with Clinically Significant Abnormalities in Digital Electrocardiogram (ECG) Measures
Part A1 and B1: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1
Part A1.1: Number of Participants With AEs and Treatment-Related AEs
+10 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part B1: M1774 and AvelumabExperimental Treatment2 Interventions
Group II: Part A3: M1774 and M4076Experimental Treatment2 Interventions
ARID1A in endometrial cancer (Part A3
Group III: Part A2: M1774 and M4076Experimental Treatment2 Interventions
ATM in prostate cancer (Part A2)
Group IV: Part A2/A3: M1774 and M4076Experimental Treatment2 Interventions
Tablet formulation (TF1, test) compared to a capsule formulation (reference)
Group V: Part A1: M1774 and M4076Experimental Treatment2 Interventions
Group VI: Part A1.1: M1774 and M4076Experimental Treatment2 Interventions
Assessment of the Effect of Food (Low-fat Meal) on the PK of M4076 Monotherapy Followed by Treatment with M1774 in Combination with M4076
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
M4076
2021
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,584 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,788 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,903 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There may be additional requirements that need to be met as stated in the study guidelines.You have recently had severe bleeding in your stomach or intestines, persistent nausea and vomiting, uncontrollable diarrhea, or difficulties absorbing medications through your digestive system.There may be additional reasons that you could be excluded from the study, as determined by the specific rules of the study.You have advanced cancer that has spread or cannot be surgically removed, and it is not responding to or you cannot tolerate the usual treatments.You have had an organ transplant, including a stem cell transplant from someone else.You have another type of cancer that is getting worse and needs treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part A2: M1774 and M4076
- Group 2: Part A3: M1774 and M4076
- Group 3: Part A1: M1774 and M4076
- Group 4: Part A2/A3: M1774 and M4076
- Group 5: Part B1: M1774 and Avelumab
- Group 6: Part A1.1: M1774 and M4076
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How perilous is M1774 for human health?
"Due to the limited data surrounding M1774, our team at Power gives it a safety rating of 1 on scale from 1 to 3. This is in part due to it being an early-stage Phase 1 trial with only minimal evidence backing its efficacy and security."
Answered by AI
Is participation in this study available to patients at the moment?
"Affirmative. Research hosted on clinicaltrials.gov verifies that the study, initially posted June 7th 2022, is actively trying to fill its ranks with 72 patients from 3 different sites."
Answered by AI
Is there a cap on the number of participants for this research endeavor?
"Indeed, the information on clinicaltrials.gov confirms that this research endeavor is recruiting subjects as of October 20th 2022. It was initially posted on June 7th and requires a total of 72 patients to be drawn from 3 distinct sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger