A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Launched by TYLIGAND PHARMACEUTICALS (SUZHOU) LIMITED · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TSN1611 for patients with advanced solid tumors that have a specific genetic mutation known as KRAS G12D. This is the first time this treatment is being given to humans, and the study is divided into two parts: one that will gradually increase the dose to find the right amount, and another that will further test this dose in more patients. The trial is currently recruiting participants who are 18 years or older and have tumors that are not responding to standard treatments or for which no standard treatment is available.

To join the study, participants need to be in relatively good health, with a life expectancy of at least three months, and have a confirmed diagnosis of a KRAS G12D mutant tumor. They should also not have any serious heart or lung issues, and they must not have had recent cancer treatments. If eligible, participants can expect to receive the study drug and undergo regular check-ups to monitor their health and the effects of the treatment. This trial represents an important step in exploring new options for patients with difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
• • The subject fully understands the requirements of the study and voluntarily signs the ICF.
• • At least 18 years of age at the time of informed consent.
• • Life expectancy of 3 months or more.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• • Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, etc.
• • Patients with adequate cardiac, liver, renal function, etc.
• • Exclusion Criteria
• Subjects will be excluded if they meet any of the following criteria:
• • Leptomeningeal disease or Active central nervous system (CNS) metastases.
• • Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of study drug.
• • Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug.
• • Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia.
• • Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug.
• • History of interstitial lung disease (ILD), drug induced IDL, or current active pneumonitis, radiation pneumonitis requiring therapeutic intervention, or uncontrolled other lung disease.
• • Any of the following in the past 6 months: myocardial infarction, unstable angina, symptomatic congestive heart failure, stroke or transient ischemic attack, pulmonary embolism.
• • Prior treatment with KRAS G12D targeted therapy.
• • Has a history or current evidence of any severe condition, concurrent therapy, or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.