RecruitingPhase 2NCT07032285

Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas

Multicenter, Open-Label Phase II Trial of Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas

Sponsor

Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas

Enrollment

25 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma (STS)

Summary

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.

Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called cirtuvivint in patients with certain types of advanced soft-tissue sarcoma — cancers that develop in muscles, fat, nerves, or other soft tissues — to see if it can slow or stop tumour growth. **You may be eligible if...** - You have been diagnosed with a specific type of advanced soft-tissue sarcoma - You are willing to follow the study treatment and monitoring schedule - Standard imaging or tests may have already been used to confirm your diagnosis **You may NOT be eligible if...** - You do not have the specific sarcoma type targeted by this drug - You have other significant health conditions that could interfere with treatment - You are not willing or able to complete study requirements 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

DRUGCirtuvivint

Cirtuvivint (SM08502) will be administered orally at 80 mg/day, 5 days on/2 days off. Cirtuvivint is supplied as tablets containing 10 mg or 50 mg of the active pharmaceutical ingredient (API). Cirtuvivint is taken with water once a day (on dosing days) at the same time every day. Doses will be taken without food (foo restriciton 1 hour before treatment and 2 hours afterdosing). Doses delayed by 12 hours will be considered missed and should not be taken. If vomiting occurs,the dose must not be retaken. Cirtuvivint is dosed in 28-day continuous cycles (28 days of treatment will beconsidered as one cycle) Treatment will continue until disease progression, unacceptable toxicity or investigator/patient decision