What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving combination therapies targeting specific genetic mutations like M1774 and M4076, often include chemotherapy, targeted therapy, and immunotherapy. Known side effects of these treatments can vary but generally include fatigue, nausea, vomiting, diarrhea, and decreased appetite. Targeted therapies may cause skin rashes, hypertension, and liver toxicity, while immunotherapies can lead to immune-related adverse events such as colitis, pneumonitis, and endocrinopathies. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several therapies targeting specific genetic mutations in solid tumors. Notable examples include pembrolizumab for tumors with high tumor mutational burden (TMB) or DNA mismatch repair deficiency, and TRK inhibitors for tumors with NTRK gene fusions. These approvals are tissue-agnostic, meaning they are based on the genetic mutation rather than the tumor's location. Additionally, combination therapies such as nivolumab plus ipilimumab have been approved for advanced melanoma, showcasing the trend towards personalized medicine in oncology.

What other types of research exist?

Promising novel alternatives for solid tumor patients include: 1) Anti-BCMA CAR T-Cell Therapy (e.g., bb2121) for relapsed or refractory multiple myeloma, 2) Teclistamab, a T cell-redirecting bispecific antibody, 3) Combination of nivolumab and ipilimumab for metastatic melanoma, and 4) BTK inhibitors (e.g., ibrutinib, acalabrutinib) combined with venetoclax for chronic lymphocytic leukemia. These therapies target specific genetic mutations and have shown significant efficacy in clinical trials.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose up to approximately 1 month

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

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

Do I qualify?Apply below to find out

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

440 Previous Clinical Trials

114,502 Total Patients Enrolled

EMD Serono Research & Development Institute, Inc.Lead Sponsor

82 Previous Clinical Trials

22,554 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

295 Previous Clinical Trials

60,908 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

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