NCT03306420

First-in-Human Study of MS201408-0005A as Single Agent and in Combinations

Phase I, First-in-Human, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of MS201408-0005A as Single Agent and Sequentially in Combinations With MS201408-0005C or MS201408-0005B in Subjects With Metastatic or Locally Advanced Unresectable Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single agent (Part IA only) and in combination with MS201408-0005C or MS201408-0005B (Part IB, Part IC).

Conditions

• Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

Type	Name	Description
DRUG	M4112	All participants who received M4112 100,200,400,600 and 800 mg twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).

Timeline

• Start date: 2017-10-03
• Primary completion: 2019-01-14
• Completion: 2019-01-14
• First posted: 2017-10-11
• Last updated: 2020-02-06
• Results posted: 2020-02-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study