Completed PHASE1 INTERVENTIONAL 18-arm NCT02278250

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

An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (Formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions Advanced Solid Tumor Solid Tumor

Interventions Carboplatin M4344 10 mg BIW M4344 100 mg BID M4344 1050 mg BIW M4344 1200 mg BIW M4344 150 mg QD M4344 160 mg BIW M4344 20 mg BIW M4344 250 mg QD M4344 300 mg BIW M4344 350 mg QD M4344 40 mg BIW M4344 400 mg M4344 450 mg BIW M4344 500 mg M4344 700 mg BIW M4344 80 mg BIW

Updated 2 times since 2024 Last updated: Mar 14, 2023 Started: Jan 26, 2015 Primary completion: Jun 16, 2021 Completion: Sep 24, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02278250, this PHASE1 trial focuses on Advanced Solid Tumor and Solid Tumor and remains completed. Sponsored by EMD Serono Research & Development Institute, Inc., it has been updated 2 times since 2015, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

2 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1

First recorded

Jan 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany

Data source: EMD Serono

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Barcelona, Spain , Boston, United States , London, United Kingdom , Madrid, Spain , Nashville, United States , New Brunswick, United States , New York, United States , Rotterdam, Netherlands , St Louis, United States and 3 more locations