TSN084 Treating Patients With Advanced Malignant Tumors

Launched by TYLIGAND BIOSCIENCE (SHANGHAI) LIMITED · Apr 23, 2024

Keywords

ClinConnect Summary

The TSN084 clinical trial is exploring a new treatment for patients with advanced malignant tumors, which are cancers that are difficult to treat with standard therapies. The study focuses on a drug called TSN084, which targets specific proteins involved in tumor growth and aims to find the highest dose that can be safely given to patients. This trial is currently recruiting participants in China who are at least 18 years old and have certain types of cancer that have either come back or are not responding to standard treatments.

To be eligible for the trial, participants should have a specific type of advanced cancer, be in relatively good health, and have a life expectancy of at least 12 weeks. They need to understand the study requirements and agree to follow the procedures. During the trial, participants will receive the medication and be monitored for its effects on their tumors and any side effects. This research could help doctors learn more about how to treat challenging cancers in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men or women ≥18 years old.
• • The subject fully understands the requirements of the study and voluntarily signs the written informed consent.
• • Be able to comply with the medication requirements of the study and all study related procedures and evaluations; not deemed as potentially unreliable and/or uncooperative.
• • Meeting the requirements of tumor types shown below. Phase Ia Study: Histological or cytological diagnosis of locally advanced, relapsed, or metastatic malignancies, not amenable to standard therapy or for which no standard therapy is available.
• • Phase Ib study: Histological or cytological diagnosis of the locally advanced, relapsed, or metastatic selected malignancies not amenable to standard therapy (disease progression or intolerance), or unable to receive standard therapy/no standard therapy is available. Malignancies with targeted mutations are preferred, including but not limited to MET exon 14 skipping mutation and MET amplification.
• • Survival expectations are ≥ 12 weeks.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 for Phase Ia, while 0 to 2 for Phase Ib.
• • Patients with adequate organ function at the time of screening.
• • Male and female patients of childbearing potential must agree to use effective methods of contraception.
• Exclusion Criteria:
• • Patients with active brain metastases, except that their central nervous system (CNS) tumor metastases are confined to the supratentorial or cerebellum, have been adequately treated (surgery or radiotherapy), have maintained radiographic stability for at least 4 weeks, and do not require corticosteroids to control symptoms.
• • Other malignancies (other than non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence) within 5 years prior to initiation of TSN084 treatment;
• • Any arterial thromboembolic event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to enrolment;
• • Uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients who do not need drainage effusion or have no significant increase in effusion after 3 days of cessation of drainage can be included).
• • Has active gastrointestinal disease or other disease, or other factors such as surgical resection that may significantly affect drug absorption, metabolism, or excretion.
• • Pregnant or lactating women.
• • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• • HIV infected patients (HIV 1/2 antibody positive).
• • Known active syphilis infection, or active tuberculosis.
• • A history of drug abuse or drug use.