TSN084 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TSN084, which aims to stop tumor growth in individuals with advanced or widespread cancer. Researchers seek to determine the safe dosage of TSN084 and to learn about its side effects and early signs of effectiveness. The trial seeks individuals with advanced cancer that cannot be treated with standard therapies and who have tumors that have spread or returned. Participants must have measurable tumors.
As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any investigational drugs or other anti-tumor drugs within 21 days before starting the trial, and you should not use strong inducers or inhibitors of CYP3A drugs.
Is there any evidence suggesting that TSN084 is likely to be safe for humans?
Research has shown that TSN084 was generally well-tolerated in early studies. In these studies, doses up to 200 mg did not cause major side effects, indicating a positive safety profile. Tests on rats and mice also demonstrated that TSN084 did not cause significant harm, further supporting its safety. These findings suggest that TSN084 could be safe for humans, but further research is necessary to confirm this.12345
Why do researchers think this study treatment might be promising?
TSN084 is unique because it introduces a new approach to cancer treatment by targeting specific cancer cell pathways that are not addressed by current therapies, such as chemotherapy and radiation. Unlike traditional treatments that often attack healthy and cancerous cells alike, TSN084 aims to selectively disrupt cancer cell growth, potentially reducing side effects. Researchers are excited about TSN084 because its novel mechanism offers hope for more effective and less harmful cancer therapies, which could improve patient outcomes significantly.
What evidence suggests that TSN084 might be an effective treatment for cancer?
Research has shown that TSN084, the investigational treatment in this trial, has promising effects against tumors in lab and animal studies. It blocks certain enzymes that help cancer cells grow. This drug targets specific enzymes like c-MET and CDK8, which are linked to various cancers. In an early study, 19 patients with hard-to-treat cancers received TSN084, and researchers observed its potential to fight tumors. Although these findings are preliminary, they offer hope for treating advanced or spreading cancers.26789
Who Is on the Research Team?
Siqing FU, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults (18+) with advanced or metastatic malignancies, who have an expected survival of at least 12 weeks and are not suitable for standard therapy. They must understand the study, consent to participate, and be able to follow procedures. Their organ functions should meet specific criteria, they cannot be pregnant or breastfeeding, and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TSN084 to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TSN084
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tyligand Bioscience (Shanghai) Limited
Lead Sponsor