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NCT05711615 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
16
Study locations

NCT05711615: Recruiting Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma, sponsored by National Cancer Institute (NCI).

NCT05711615 is a Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 40-participant average among 12 other Metastatic Sarcoma trials with a reported enrollment target (25% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05711615, a Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
16
Study locations

Study 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.

Primary Outcome

The number and type of DLT seen at each dose level will be provided. The adverse events (AEs) will also be summarized by AE type and the maximum grade of the AE experienced by the patient for each dose level. DLT will be used to determine the recommended phase 2 dose of study drugs.

Conditions Studied

Metastatic Sarcoma Metastatic Dedifferentiated Liposarcoma Metastatic Leiomyosarcoma Unresectable Dedifferentiated Liposarcoma Unresectable Leiomyosarcoma Metastatic Undifferentiated Pleomorphic Sarcoma Unresectable Sarcoma Metastatic Myxofibrosarcoma Metastatic Synovial Sarcoma Unresectable Myxofibrosarcoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • PROCEDURE Echocardiography Test

Study Locations (16)

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago
  • UC Comprehensive Cancer Center at Silver Cross - New Lenox
  • University of Chicago Medicine-Orland Park - Orland Park

California

  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda

Missouri

  • Washington University School of Medicine - St Louis
  • Siteman Cancer Center-South County - St Louis

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Florida

  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-02-06
Est. Completion 2026-05-03
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT05711615 shows while recruiting

NCT05711615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 40-participant average among 12 other Metastatic Sarcoma trials with a reported enrollment target (25% lower).

The record links to 10 conditions, with Metastatic Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05711615 lists 16 locations in 11 states (Illinois, California, Maryland).

Frequently Asked Questions

What is clinical trial NCT05711615 about?

NCT05711615 is a clinical study titled "Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma". 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) an...

What is the current status of trial NCT05711615?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-02-06. Estimated completion is 2026-05-03.

What conditions does trial NCT05711615 study?

This clinical trial studies the following conditions: Metastatic Sarcoma, Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma, Unresectable Dedifferentiated Liposarcoma, Unresectable Leiomyosarcoma.

What interventions are being tested in trial NCT05711615?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE).

Who is sponsoring clinical trial NCT05711615?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05711615 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Sarcoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05711615's enrollment target sits among peer trials

30 7th of 12 higher than 6 of 12 other Metastatic Sarcoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05711615

Source: ClinicalTrials.gov NCT05711615, the US trial registry maintained by the National Library of Medicine. NCT05711615 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.