Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Public ClinicalTrials.gov record NCT05711615. 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
A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin in Patients With Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) and for which no known cure is available (advanced). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also enhance the activity of chemo- and radiotherapy. There is some pre-clinical evidence in animal models that combining peposertib with liposomal doxorubicin can shrink or stabilize certain types of cancer for longer than either drug alone, but it is not known if this will happen in people. Combination therapy with liposomal doxorubicin and peposertib may be effective in treating patients with advanced sarcoma.
Study identification
- NCT ID
- NCT05711615
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Conditions
- Metastatic Dedifferentiated Liposarcoma
- Metastatic Leiomyosarcoma
- Metastatic Myxofibrosarcoma
- Metastatic Sarcoma
- Metastatic Synovial Sarcoma
- Metastatic Undifferentiated Pleomorphic Sarcoma
- Unresectable Dedifferentiated Liposarcoma
- Unresectable Leiomyosarcoma
- Unresectable Myxofibrosarcoma
- Unresectable Sarcoma
- Unresectable Synovial Sarcoma
- Unresectable Undifferentiated Pleomorphic Sarcoma
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Echocardiography Test Procedure
- Magnetic Resonance Imaging Procedure
- Multigated Acquisition Scan Procedure
- Pegylated Liposomal Doxorubicin Hydrochloride Drug
- Peposertib Drug
Procedure · 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
- Feb 5, 2024
- Primary completion
- Nov 2, 2026
- Completion
- Nov 2, 2026
- Last update posted
- Sep 3, 2026
2024 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | Recruiting |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | Recruiting |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Recruiting |
| National Cancer Institute Developmental Therapeutics Clinic | Bethesda | Maryland | 20892 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Suspended |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05711615, 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 Sep 3, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05711615 live on ClinicalTrials.gov.