A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WX390, Toripalimab.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
Overview
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.
Detailed description
This study will be an open-label, multicenter phase Ib/IIa clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
Interventions
- Drug WX390
WX390 tablet, once a day - Drug Toripalimab
240 mg, Day 1, every 3 weeks
Primary outcome measures
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period [Time frame: up to 24 weeks]
- Progression-free survival rate (PFS rate) [Time frame: up to 24 weeks]
- Objective response rate (ORR) [Time frame: up to 24 weeks]
Secondary outcome measures (3)
- Progression-free survival (PFS) [Time frame: up to 48 weeks]
- Overall survival (OS) [Time frame: up to 48 weeks]
- Disease-control rate (DCR) [Time frame: up to 24 weeks]
Eligibility criteria
Inclusion criteria
- ≥18 years of age
- Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of more than 3 months
- At least one measurable lesion according to RECIST 1.1
- Adequate organ function，
- Signed and dated informed consent
Exclusion criteria
- Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
- Major surgery within 30 days prior to the initiation of study treatment
- Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
- Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
- Patients who are suffering active interstitial lung disease
- Evidence of ongoing or active serious infection
- History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection
- Inability to take medication orally
- Abuse of alcohol or drugs
- People with cognitive and psychological abnormality or with low compliance
- Pregnant or lactating women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the first affiliated hospital of Jilin university — Changchun
Identifiers
NCT: NCT06117566 · JYP0390M203