New treatment for patients with advanced malignant tumors

A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TSN084 Tablets in Patients With Advanced Malignant Tumors.

This study is testing a new drug called TSN084 to see if it can help people with advanced cancer feel better and how much of the drug is safe to use.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tyligand Bioscience (Shanghai) Limited (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06386705 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates TSN084, a novel type II kinase inhibitor, in patients with advanced or metastatic malignant tumors. The study is divided into two phases: Phase 1a focuses on determining the maximum tolerated dose (MTD) and recommended dose for further investigation, while Phase 1b assesses the drug's clinical activity and efficacy in specific cohorts of patients with different tumor types. The trial aims to gather data on the pharmacokinetics, safety, and preliminary anti-tumor activity of TSN084 in a Chinese population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced, relapsed, or metastatic tumors that are not amenable to standard therapy.

Not a fit: Patients with early-stage tumors or those who can receive standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignancies that are resistant to standard therapies.

How similar studies have performed: Other studies involving kinase inhibitors have shown promise in treating similar malignancies, suggesting potential for success with this approach.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
• Peking university cancer hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jie Wang, MD, PhD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Tyligand Clinical Trial Info

Conditions Malignant Neoplasm