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drugset / Trial / NCT02278250

First in Human Study of M4344 in Participants With Advanced Solid Tumors

NCT02278250 ↗

Phase 1 Completed 97 enrolled EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.

Timeline

Start
2015-01-26
Primary completion
2021-06-16
Completion
2021-09-24

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject M4344 Small molecule 10 mg Oral
Subject M4344 Small molecule 20 mg Oral
Subject M4344 Small molecule 40 mg Oral
Subject M4344 Small molecule 80 mg Oral
Subject M4344 Small molecule 100 mg Oral
Subject M4344 Small molecule 150 mg Oral
Subject M4344 Small molecule 160 mg Oral
Subject M4344 Small molecule 250 mg Oral
Subject M4344 Small molecule 300 mg Oral
Subject M4344 Small molecule 350 mg Oral
Subject M4344 Small molecule 400 mg Oral
Subject M4344 Small molecule 450 mg Oral
Subject M4344 Small molecule 500 mg Oral
Subject M4344 Small molecule 700 mg Oral
Subject M4344 Small molecule 1050 mg Oral
Subject M4344 Small molecule 1200 mg Oral
Background Carboplatin Small molecule 5 unknown Intravenous

Indications

cancer