Trials / Completed
CompletedNCT04882917
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
A First-in-human, Phase I, Open-label Study of the ATM Inhibitor M4076 in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 410)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M4076 | M4076 was administered orally. |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2021-05-12
- Last updated
- 2025-03-07
- Results posted
- 2025-03-07
Locations
3 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04882917. Inclusion in this directory is not an endorsement.