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Cancer Vaccine
M1069 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first dose of study drug up to planned assessment at 18.2 months
Awards & highlights
Summary
This trial is testing a new drug called M1069 to see if it is safe and effective for people with advanced solid cancers. Researchers are looking at how the drug moves through the body and interacts with cancer cells. They also want to find out if there are any early signs that it helps treat the cancer.
Eligible Conditions
- Metastatic or Locally Advanced Unresectable Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from first dose of study drug up to planned assessment at 18.2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first dose of study drug up to planned assessment at 18.2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Profile as Assessed by Incidence of Adverse Events (AEs), Treatment-Related AEs and Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Change from Baseline in Corrected QT (QTc) Interval Over Time
Change from Baseline in Tumor Microenvironment (TME) in Available Paired Tumor Biopsies at Cycle 2 Day 15
Duration of Response (DoR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: M1069Experimental Treatment1 Intervention
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Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
81 Previous Clinical Trials
30,950 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
439 Previous Clinical Trials
114,900 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
293 Previous Clinical Trials
69,349 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced or spread-out cancer that hasn't responded to standard treatments or isn't expected to benefit from them.There may be additional criteria specific to the study that could exclude you from participating.You have undergone organ transplantation, including receiving stem cells from someone else.You are able to swallow pills or capsules.There may be additional requirements for participation that are specific to the study.
Research Study Groups:
This trial has the following groups:- Group 1: M1069
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.
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