M1774 for Metastatic or Locally Advanced Unresectable Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic or Locally Advanced Unresectable Solid TumorsM1774 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing the safety and tolerability of M1774 when given with either Drug A or Drug B to people with metastatic or locally advanced unresectable solid tumors.

Eligible Conditions
  • Metastatic or Locally Advanced Unresectable Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 6 Secondary · Reporting Duration: Baseline up to 18 months

Month 18
Part A1 and B1: Number of Participants with Clinically Significant Abnormalities in Digital Electrocardiogram (ECG) Measures
Part A1: Number of Participants with Adverse Events (AEs) and Treatment-Related AEs
Part B1: Number of Participants with Adverse Events (AEs) and Treatment-Related AEs
Part B1: Number of Participants with Any Positive Anti-Drug Antibody (ADA) of Drug B
Day 28
Part A1: Number of Participants with Dose-Limiting Toxicities (DLTs) During the DLT Evaluation Period
Part B1: Number of Participants with Dose-Limiting Toxicities (DLTs) During the DLT Evaluation Period
Month 1
Part A1: Change from Baseline in Pharmacodynamic (PD) Biomarker
Part B1: Change from Baseline in Pharmacodynamic (PD) Biomarker
Month 18
Part B1: Pharmacokinetic (PK) Serum Concentration of Drug B
Month 6
Part A1: Pharmacokinetic (PK) Plasma Concentration of M1774 and Drug A
Part B1: Pharmacokinetic (PK) Plasma Concentration of M1774
Month 18
Part A1 and B1: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Part A1: M1774 and Drug A
1 of 2
Part B1: M1774 and Drug B
1 of 2

Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: M1774 · No Placebo Group · Phase 1

Part A1: M1774 and Drug AExperimental Group · 2 Interventions: M1774, Drug A (DNA Damage Response Inhibitor) · Intervention Types: Drug, Drug
Part B1: M1774 and Drug BExperimental Group · 2 Interventions: M1774, Drug B (Immune Checkpoint Inhibitor) · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 18 months

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
429 Previous Clinical Trials
112,867 Total Patients Enrolled
3 Trials studying Metastatic or Locally Advanced Unresectable Solid Tumors
175 Patients Enrolled for Metastatic or Locally Advanced Unresectable Solid Tumors
EMD Serono Research & Development Institute, Inc.Lead Sponsor
74 Previous Clinical Trials
29,935 Total Patients Enrolled
3 Trials studying Metastatic or Locally Advanced Unresectable Solid Tumors
175 Patients Enrolled for Metastatic or Locally Advanced Unresectable Solid Tumors
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
279 Previous Clinical Trials
67,271 Total Patients Enrolled
3 Trials studying Metastatic or Locally Advanced Unresectable Solid Tumors
175 Patients Enrolled for Metastatic or Locally Advanced Unresectable Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have adequate hematological, hepatic, and renal function as defined in the protocol.