First in Human Study of M4344 in Participants With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT02278250. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.
Study identification
- NCT ID
- NCT02278250
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Interventions
- M4344 10 mg BIW Drug
- M4344 20 mg BIW Drug
- M4344 40 mg BIW Drug
- M4344 80 mg BIW Drug
- M4344 160 mg BIW Drug
- M4344 300 mg BIW Drug
- M4344 450 mg BIW Drug
- M4344 700 mg BIW Drug
- M4344 1050 mg BIW Drug
- M4344 1200 mg BIW Drug
- M4344 100 mg BID Drug
- M4344 150 mg QD Drug
- M4344 250 mg QD Drug
- M4344 350 mg QD Drug
- M4344 400 mg Drug
- M4344 500 mg Drug
- Carboplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 25, 2015
- Primary completion
- Jun 15, 2021
- Completion
- Sep 23, 2021
- Last update posted
- Mar 15, 2023
2015 – 2021
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-5901 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 8903 | — |
| Memorial Sloan-Kettering Cancer Center (MSKCC) | New York | New York | 10065 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Froedtert & The Medical College of Wisconsin | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02278250, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2023 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02278250 live on ClinicalTrials.gov.