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DNA Damage Response Inhibitor

M1774 + Niraparib 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
Presence of loss of function mutations in the genes for ARID1A, ATRX and /or DAXX and ATM
Female participants not pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2.2 years
Awards & highlights

Study Summary

This trial is testing a new drug, M1774, to see if it is safe and effective when used alone or with another drug, niraparib.

Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to standard treatments or have no suitable standard options. They should be relatively healthy (ECOG <=1), possibly with treated, symptom-free brain metastases. Specific genetic mutations are required for some parts of the study, and participants must not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests M1774 alone and combined with Niraparib, a PARP inhibitor, in people with certain solid tumors. It's an early-phase study to determine safety, tolerability, how the body processes the drugs (with/without food), and any preliminary signs of effectiveness.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from similar drugs include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems; organ function issues; allergic reactions; and potential drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has specific genetic mutations in ARID1A, ATRX, DAXX, or ATM.
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I am not pregnant or breastfeeding.
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I weigh less than 77 kg or my platelet count is below 150,000/mm^3.
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I do not have cancer cells in the lining of my brain and spinal cord.
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I weigh at least 77 kg and my platelet count is 150,000 or higher.
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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2.2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2.2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A1, A3, A4, A5 and B1: Number of Participants With Abnormalities in Vital Signs
Part A1, A3, A4, A5 and B1: Number of Participants With Clinical Significant Abnormalities in Electrocardiogram (ECG) Findings
Part A1, A3, A4, A5 and B1: Number of Participants With Grade 3 or Higher Laboratory Findings According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
+10 more
Secondary outcome measures
Part A1, A3, A4 and A5 : Dose Normalized Area Under Concentration-Time Curve From Time Zero to Last Sampling Time (AUC0-t/Dose) of M1774
Part A1, A3, A4 and A5: Accumulation Ratio for Area Under the Plasma Concentration Concentration-Time Curve (Racc[AUC]) of M1774
Part A1, A3, A4 and A5: Accumulation Ratio of Maximum Observed Plasma Concentration (Racc[Cmax]) of M1774
+79 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part B1: Combination Therapy Dose FindingExperimental Treatment2 Interventions
B1a: Participants with baseline body weight less than (<) 77 kilogram (kg) or platelets <150,000 cubic per millimeter (mm^3) will receive Niraparib once daily combined with different doses of M1774. B1b: Participants with baseline body weight greater than or equal to (>=) 77 kg and or platelets >= 150,000 mm^3 will receive Niraparib once daily combined with different doses of M1774 and schedule determined as recommended dose for expansion (RDE) in Part B1a.
Group II: Part A5: China Dose Confirmation MonotherapyExperimental Treatment1 Intervention
Starting at global RDE from Part A1, in China. Participants will initially receive M1774 once daily under fasting conditions. Additional schedules may be evaluated if needed.
Group III: Part A4: Japan Dose Confirmation MonotherapyExperimental Treatment1 Intervention
Starting at global RDE from Part A1, in Japan. Participants will initially receive M1774 once daily under fasting conditions. Additional schedules may be evaluated if needed.
Group IV: Part A3 - Monotherapy ExpansionExperimental Treatment1 Intervention
Part A3 is an expansion of Part A1 where M1774 will be administered as a single agent at the RDE established in Part A1. Participants with defined loss-of-function mutation in ARID1A, ATRX and/or DAXX, and ATM will be enrolled.
Group V: Part A2 - Preliminary Food Effect AssessmentExperimental Treatment1 Intervention
Participants in the food effect assessment will receive M1774 at the dose and schedule determined as recommended dose for expansion (RDE) in Part A1. A single dose of M1774 will be administered on Day -7 under a fed (low-fat meal) or fasted condition, followed by a 1-week washout period. After completion of the scheduled food effect assessments, participants will follow the same schedule as participants in Part A1.
Group VI: Part A1: Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will initially receive M1774 once daily under fasting conditions. Additional schedules may be evaluated if needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
114,418 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,656 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,794 Total Patients Enrolled

Media Library

M1774 (DNA Damage Response Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04170153 — Phase 1
Solid Tumors Research Study Groups: Part B1: Combination Therapy Dose Finding, Part A1: Monotherapy Dose Escalation, Part A4: Japan Dose Confirmation Monotherapy, Part A5: China Dose Confirmation Monotherapy, Part A3 - Monotherapy Expansion, Part A2 - Preliminary Food Effect Assessment
Solid Tumors Clinical Trial 2023: M1774 Highlights & Side Effects. Trial Name: NCT04170153 — Phase 1
M1774 (DNA Damage Response Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04170153 — Phase 1

Frequently Asked Questions

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

Have there been any prior investigations concerning M1774?

"At the moment, 99 medical trials are focusing on M1774 and 13 of them have entered Phase 3. Washington, District of Columbia is one such location undertaking these tests however a total of 2817 sites globally are conducting research into this drug."

Answered by AI

Is this study a groundbreaking exploration of its kind?

"Since 2016, Myriad Genetics has undertaken numerous trials for M1774. After its initial study in which 733 participants were involved, the drug was approved to enter Phase 3 testing. Presently 99 experiments are being conducted worldwide with sites located across 485 cities and 49 nations."

Answered by AI

Is recruitment for participants open for this experiment?

"According to the clinicaltrials.gov database, this trial is actively recruiting candidates with its first post dated December 20th 2019 and last edit on April 27th 2022."

Answered by AI

Has the Food and Drug Administration sanctioned M1774?

"The safety of M1774 is estimated to be a 1 since it is currently undergoing the first stage of clinical trials, which limits our understanding of its efficacy and security."

Answered by AI

What is the capacity of this research project in terms of participant numbers?

"Affirmative. Clinicaltrials.gov indicates that this trial is presently attempting to recruit patients, with the first posting dating back to December 20th 2019 and the most recent update on April 27th 2022. A total of 130 individuals are needed from 2 separate centres."

Answered by AI
~39 spots leftby Mar 2025