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TERMINATED
NCT05198349
PHASE1

First in Human Study of M1069 in Advanced Solid Tumors

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2022-03-02

Completion Date

2023-08-10

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

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.

Locations (3)

Hackensack University Medical Center

Hackensack, New Jersey, United States

Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

Nashville, Tennessee, United States

Princess Margaret Cancer Centre

Toronto, Canada