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Trial Title:
A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
NCT ID:
NCT06117566
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
WX390
Description:
WX390 tablet, once a day
Arm group label:
WX390 0.5 mg + Toripalimab 240mg
Arm group label:
WX390 0.7 mg + Toripalimab 240mg
Arm group label:
WX390 0.9 mg + Toripalimab 240mg
Other name:
WXFL10030390
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
240 mg, Day 1, every 3 weeks
Arm group label:
WX390 0.5 mg + Toripalimab 240mg
Arm group label:
WX390 0.7 mg + Toripalimab 240mg
Arm group label:
WX390 0.9 mg + Toripalimab 240mg
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the first affiliated hospital of Jilin university
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanhua Ding, PhD
Investigator:
Last name:
Yanhua Ding, PhD
Email:
Principal Investigator
Start date:
November 18, 2022
Completion date:
March 2025
Lead sponsor:
Agency:
Shanghai Jiatan Pharmatech Co., Ltd
Agency class:
Industry
Source:
Shanghai Jiatan Pharmatech Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117566
