TSN1611 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part.
Do I have to stop taking my current medications for the TSN1611 trial?
The trial requires that you have not had any prior systemic anti-cancer treatment within 21 days or 5 half-lives before the first dose of the study drug. It does not specify about other medications, so you should discuss your current medications with the study team.
What safety data exists for TSN1611 (irinotecan) in humans?
What data supports the effectiveness of the drug TSN1611 for cancer?
Research shows that irinotecan, a component of TSN1611, has been effective in treating advanced colorectal cancer and non-small-cell lung cancer, with some patients experiencing a positive response. Additionally, combinations of irinotecan with other drugs have shown promise in treating advanced gastric cancer.678910
Who Is on the Research Team?
Cindy Li
Principal Investigator
Tyligand Bioscience (Shanghai) Limited
Are You a Good Fit for This Trial?
This trial is for people with advanced solid tumors that have a specific genetic change called KRAS G12D mutation. Details on who can join or reasons for exclusion are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Evaluation of prespecified dose levels of TSN1611 to determine the maximum tolerated dose or recommended phase 2 dose
Phase 2: Dose Expansion
Evaluation of the efficacy and safety of TSN1611 as monotherapy at the recommended dose in separate groups of patients
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TSN1611
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tyligand Bioscience (Shanghai) Limited
Lead Sponsor
Tyligand Pharmaceuticals (Suzhou) Limited
Lead Sponsor