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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 pre-dose up to approximately 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and best dose of two drugs, tuvusertib and lartesertib, in patients with specific cancers. It also examines how food affects lartesertib and compares different forms of tuvusertib. The study includes patients with prostate and endometrial cancers with specific genetic mutations, as well as those with advanced 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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to approximately 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to approximately 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A1: Change From Baseline in Pharmacodynamic (PD) Biomarker
Part B1: Change From Baseline in PD Biomarker

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Part B1: Tuvusertib and AvelumabExperimental Treatment2 Interventions
Group II: Part A3: Tuvusertib and LartesertibExperimental Treatment2 Interventions
ARID1A in endometrial cancer
Group III: Part A2: Tuvusertib and LartesertibExperimental Treatment2 Interventions
ATM in prostate cancer (Part A2)
Group IV: Part A2/A3: Tuvusertib and LartesertibExperimental Treatment2 Interventions
Tablet formulation (TF1, test) compared to a capsule formulation (reference)
Group V: Part A1: Tuvusertib and LartesertibExperimental Treatment2 Interventions
Group VI: Part A1.2: Tuvusertib and LartesertibExperimental Treatment2 Interventions
Relative Bioavailability Assessment of Tuvusertib Tablet (TF1) vs Capsule Followed by Treatment with Tuvusertib in Combination with Lartesertib
Group VII: Part A1.1: Tuvusertib and LartesertibExperimental 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
2017
Completed Phase 2
~2440

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors, such as the combination of M1774 and M4076, often involve DNA damage response inhibitors and immune checkpoint inhibitors. DNA damage response inhibitors prevent cancer cells from repairing their DNA, leading to cell death, while immune checkpoint inhibitors enhance the immune system's ability to recognize and destroy cancer cells by blocking proteins that suppress immune responses. This targeted approach is crucial for patients with specific genetic mutations, as it can improve treatment efficacy and reduce side effects compared to traditional chemotherapy.
New molecular targets in malignant gliomas.

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,830 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,661 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
61,107 Total Patients Enrolled

Media Library

Avelumab (Immune Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05396833 — Phase 1
Solid Tumors Research Study Groups: Part A2/A3: Tuvusertib and Lartesertib, Part A1.1: Tuvusertib and Lartesertib, Part A1.2: Tuvusertib and Lartesertib, Part A2: Tuvusertib and Lartesertib, Part A3: Tuvusertib and Lartesertib, Part A1: Tuvusertib and Lartesertib, Part B1: Tuvusertib and Avelumab
Solid Tumors Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT05396833 — Phase 1
Avelumab (Immune Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396833 — Phase 1
~24 spots leftby Mar 2026