Clinical trial NCT06117566: A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Shanghai Jiatan Pharmatech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: WX390 continuous oral dosing (0.5 mg once a day) WX390 continuous oral dosing (0.7 mg once a day) WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period
timeFrame: up to 24 weeks
measure: Progression-free survival rate (PFS rate)
timeFrame: up to 24 weeks
measure: Objective response rate (ORR)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 48 weeks
measure: Overall survival (OS)
timeFrame: up to 48 weeks
measure: Disease-control rate (DCR)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: the first affiliated hospital of Jilin university
state: Jilin
Study officials:
affiliation: the first affiliated hospital of Jilin university
name: Yanhua Ding, PhD
role: PRINCIPAL_INVESTIGATOR
References: