Clinical trials

This is a Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study to evaluate the efficacy of WX390 in combination with toripalimab versus investigator's choice of therapy in patients with recurrent or metastatic cervical cancer who have failed at least one prior platinum-based systemic therapy, as assessed by overall survival (OS).

This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant pulmonary tuberculosis. Approximately 450 participants will be screened over a period of up to 2 weeks and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline, in combination with placebo tablets and BR, for 24 weeks. After the treatment period, participants will enter a background regimen period up to Week 72, during which they will continue to receive BR. A subset of participants will be included in the C-QT sub-study to assess intensive PK sampling and 12-lead ECG evaluations on Day 1 pre-dose, Day 14, and Week 24. The study aims to provide robust data to support the use of Sudapyridine as a treatment option for rifampicin-resistant pulmonary tuberculosis.

The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are: How does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine? Participants will: Take Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence. Attend multiple clinic visits for blood sample collection and safety evaluations. Researchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are: * Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment. * Safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.

This single-center, open-label, non-randomized study aims to evaluate the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) following a single oral dose of \[U-14C\] WX-081 in healthy Chinese male volunteers. A total of 6-10 subjects will be enrolled to obtain complete samples and data from at least six participants. Biological samples, including blood, plasma, urine, and feces, will be collected over a specified time period. The study will assess pharmacokinetic parameters, excretion pathways, and identify major metabolites contributing to over 10% of plasma exposure.

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced solid tumors. The main questions it aims to answer are: * the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390; * safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.

The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are: * PFS, OS, DoR at week 48; * antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.