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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

Study Summary

This trial is testing a new drug, M1069, for safety, side effects, and how well it works in people with advanced 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose of study drug up to planned assessment at 18.2 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

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 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: M1069Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,845 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,641 Total Patients Enrolled

Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.

288 Previous Clinical Trials

68,960 Total Patients Enrolled

Media Library

M1069 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05198349 — Phase 1

Solid Tumors Research Study Groups: M1069

Solid Tumors Clinical Trial 2023: M1069 Highlights & Side Effects. Trial Name: NCT05198349 — Phase 1

M1069 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198349 — Phase 1

Frequently Asked Questions

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

Is M1069 a reliable medication with few risks for patients?

"Our Power team assessed the security of M1069 at a 1 rating due to being in Stage 1 with restricted data supporting safety and effectiveness."

Answered by AI

Are participants currently being recruited for this experiment?

"Affirmative. Data from clinicaltrials.gov affirms that this research endeavor, which was posted on March 2nd 2022, is actively seeking participants. Approximately 30 individuals need to be recruited across 3 distinct medical facilities."

Answered by AI

What is the cap for participants in this clinical examination?

"Affirmative. The clinical trial's information hosted on clinicaltrials.gov clearly states that the project is actively recruiting patients, having been initially posted on March 2nd 2022 and recently updated November 4th 2022. 30 participants need to be sourced from 3 distinct medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First in Human Study of M1069 in Advanced Solid Tumors

2022. "First in Human Study of M1069 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05198349.