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Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas

NCT07032285 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma (STS)

Interventions

DRUG

Cirtuvivint

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

Sponsors & Collaborators

  • TenaRx, Inc.

    collaborator INDUSTRY

  • Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2027-04-30
Completion
2027-07-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07032285 on ClinicalTrials.gov