Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
Spain25 participantsStarted 2025-01-15
Plain-language 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.
Who can participate
Age range16 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow up. Informed consent must be obtained prior to the start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g., imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
✓. Metastatic/locally advanced with recent progression (\<6 months).
✓. Patients should have received at least anthracyclines previously unless not indicated (SFT).
✓. Measurable disease according to RECIST 1.1 criteria.
✓. Patients must be willing to provide consent for the provision of mandatory biological samples for central pathology review (tumor sample from the three months prior to the start of treatment if the patient has not received any systemic therapy) and translational study (tumor blocks and blood).
What they're measuring
1
To evaluate the progression-free survival rate (PFSR) at 3 months.
Timeframe: 3 months
Trial details
NCT IDNCT07032285
SponsorAsociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Exclusion criteria
✕. Previous treatment with CLK inhibitors.
✕. Patients who have received any other anti-cancer therapy or investigational product in the last 28 days prior to enrollment.
✕. Four or more systemic therapy lines for advanced disease.
✕. Sarcoma subtypes other than the specified in the inclusion criteria.
✕. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 3 years prior to enrollment. Cancer treated with curative intent for \>5 years previously and without evidence of recurrence will be allowed.
✕. Any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
✕. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.