NCT05198349

First in Human Study of M1069 in Advanced Solid Tumors

First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M1069 in Participants 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

The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.

Conditions

• Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

Type	Name	Description
DRUG	M1069	Participants received escalated oral dose of M1069, twice daily (BID) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Timeline

• Start date: 2022-03-02
• Primary completion: 2023-05-09
• Completion: 2023-08-10
• First posted: 2022-01-20
• Last updated: 2024-11-25

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study