Actively Recruiting
Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
Led by Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas · Updated on 2026-04-06
25
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
A
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Lead Sponsor
T
TenaRx, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is a Phase 2 clinical trial of the drug cirtuvivint as a second-line treatment for advanced soft tissue sarcomas. The study is being conducted in Spain and is expected to enroll approximately 25 patients in total. The primary objective of this Phase 2 study is to evaluate the efficacy of treatment with cirtuvivint. Cirtuvivint is an anti-cancer medication developed by the U.S. company Biosplice Therapeutics, Inc. This drug is an inhibitor of the enzymes CLK1-4 and DYRK1-4 (molecules involved in the cell cycle) and is administered as oral tablets. This product is still under investigation and has not yet been approved in Europe.
CONDITIONS
Official Title
Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to comply with study procedures and follow-up
- Aged between 16 and 70 years
- Diagnosis of advanced unresectable soft-tissue sarcoma of specified subtypes (solitary fibrous tumor, synovial sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma, alveolar soft part sarcoma, myxoid liposarcoma); 2 desmoid tumor patients may be included as proof of concept
- Metastatic or locally advanced disease with progression within the last 6 months
- Previous treatment with at least anthracyclines unless not indicated for solitary fibrous tumor
- Measurable disease according to RECIST 1.1 criteria
- Consent to provide mandatory biological samples for central pathology review and translational studies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate liver, kidney, heart, and blood function as defined by specific laboratory criteria
- Absolute neutrophil count ≥1500/mm³, platelet count ≥100,000/mm³, bilirubin ≤1.5 mg/dL, AST and ALT ≤2.5 times upper limit of normal, creatinine ≤1.5 mg/dL
- Left ventricular ejection fraction ≥50% by echocardiogram or MUGA scan
- Negative pregnancy test within 72 hours prior to enrollment for females of childbearing potential and agreement to use effective contraception during treatment and 3 months after
- Willingness to avoid extensive sun exposure, phototherapy, and tanning salons during trial participation
You will not qualify if you...
- Prior treatment with CLK inhibitors
- Receipt of any other anti-cancer or investigational therapy within 28 days before enrollment
- Four or more prior systemic therapy lines for advanced disease
- Sarcoma subtypes other than those specified in inclusion criteria
- Previous malignancy requiring treatment or recurrence within 3 years prior to enrollment except certain treated cancers; cancers treated with curative intent over 5 years ago without recurrence allowed
- Any concurrent medical condition likely to interfere with study procedures, including uncontrolled hypertension, diabetes, or active systemic infection
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first treatment day
- Pregnancy or breastfeeding
- Body surface area less than 1.4 m2 at baseline
- Life expectancy under 3 months
- Major surgery within 28 days prior to first treatment day
- Active gastrointestinal dysfunction affecting ability to swallow or absorb tablets
- Inability or unwillingness to take recommended supportive medications for nausea or anorexia/cachexia
- Serious psychiatric, medical, or other conditions that may interfere with treatment or consent
- Corrected QT interval (QTc) over 480 msec or specific cardiac arrhythmias
- History of myocardial infarction within 1 year, class II-IV congestive heart failure, or significant coronary artery disease
- Use or anticipated use of drugs strongly affecting CYP3A4 within 10 days prior to first dose
- Retinal abnormalities increasing risk
- Known active HIV, hepatitis B, or hepatitis C infection
- Unwillingness to participate in mandatory translational research with tumor and blood samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical Oncology Department, HU Fundación Jimenez Diaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
N
Nadia Hindi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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