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

Not Recruiting

Trial ID: NCT05269355


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.

Official Title

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

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)


Key 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

   - At least 4 weeks since prior surgery and recovered in the opinion of investigator

Key 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.

Note: Other inclusion and exclusion criteria may apply.


drug: Unesbulin

drug: Dacarbazine

other: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern

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