RecruitingPhase 1NCT05711615

Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma

A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin in Patients With Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas


Sponsor

National Cancer Institute (NCI)

Enrollment

30 participants

Start Date

Feb 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of low-dose liposomal doxorubicin (a standard chemotherapy given in a protective coating) with peposertib (a newer targeted cancer drug) in patients with advanced soft tissue sarcoma — a rare type of cancer in muscle or connective tissue. **You may be eligible if...** - You are 18 or older with advanced sarcoma that cannot be surgically removed and for which no cure exists - You have been previously treated with at least one other therapy - Your specific sarcoma type is leiomyosarcoma, myxofibrosarcoma, undifferentiated pleomorphic sarcoma, synovial sarcoma, or dedifferentiated liposarcoma - Your physical condition is good enough to participate (ECOG 0–2) - Your blood counts, liver, and kidney function meet acceptable levels **You may NOT be eligible if...** - You have had a cumulative dose of anthracycline (doxorubicin-class) chemotherapy above 360 mg/m² previously - You have serious heart problems - You have had certain prior treatments that disqualify participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGPegylated Liposomal Doxorubicin Hydrochloride

Given IV

DRUGPeposertib

Given PO


Locations(16)

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05711615


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