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A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)

A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma

NCT05269355•PTC Therapeutics

View on ClinicalTrials.gov

Summary

This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological or cytological confirmation of LMS arising at any anatomic site except bone sarcoma, unresectable or metastatic, relapsed or refractory disease measurable per RECIST 1.1 criteria
•Disease progression on previous treatment before screening or intolerability to other oncology treatments
•Participants with liver metastases may be enrolled
•Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled.
•Toxicity from prior therapies recovered to Grade ≤1 or participant's baseline, except for alopecia. In addition, endocrinopathies associated with prior immunotherapy-based treatments that are well controlled on replacement medication are not exclusionary.
•At least 1 prior systemic cytotoxic or targeted therapy regimen for LMS, which may include but is not limited to single-agent doxorubicin or other anthracycline, doxorubicin plus ifosfamide, trabectedin, pazopanib, or gemcitabine with or without docetaxel.
•At least 4 weeks since prior surgery and recovered in the opinion of investigator

Exclusion Criteria

•Received temozolomide or dacarbazine at any time
•Any other systemic anticancer therapy including investigational agents ≤3 weeks before initiation of study treatment. Additionally, participants may not have received radiation ≤3 weeks before initiation of study treatment.
•Known intolerance to dacarbazine or one or more of the excipients in unesbulin.
•Co-existing active infection or any co-existing medical condition likely to interfere with study procedures
•Gastrointestinal disease or other conditions that could affect absorption. Active peptic ulcer disease, active gastritis, or previous history of gastric perforation within the last 2 years
•Major surgery, open biopsy, or significant traumatic injury that has not recovered, in the opinion of the investigator, within 28 days of baseline
•Immunization with a live vaccine within 30 days before starting study drug due to the risk of serious and life-threatening infections.
•Prior malignancies, other than LMS, that required treatment or have shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ, prostate cancer in situ or any other low risk malignancy that is approved by the medical monitor) during the 5 years before initiation.
•Prior or ongoing clinically significant illness, medical or psychiatric condition, medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, or alter the absorption, distribution, metabolism, or excretion of the study drugs, or could impair the assessment of study results.

Locations (54)

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Sarcoma Oncology Research Center

Santa Monica, California, United States

Stanford Cancer Center

Stanford, California, United States

University of Colorado Denver

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Florida (UF) Health Cancer Center - Orlando Health

Orlando, Florida, United States

Moffitt

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Key Dates

Start Date

May 23, 2022

Primary Completion Date

June 17, 2024

Completion Date

July 17, 2024

Last Updated

June 13, 2025

Enrollment

359

ACTUAL participants

Conditions

Leiomyosarcoma

Interventions

Unesbulin

DRUG

Dacarbazine

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)

Inclusion Criteria

Exclusion Criteria

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