A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Jiatan Pharmatech Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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)
Trial design
Design model
Sequential
Treatments tested in this trial
WX390
DrugWX390 tablet, once a day
Toripalimab
Drug240 mg, Day 1, every 3 weeks
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: WX390 0.5 mg + Toripalimab 240mgExperimental treatment 2 interventions
Group B: WX390 0.7 mg + Toripalimab 240mgExperimental treatment 2 interventions
Group C: WX390 0.9 mg + Toripalimab 240mgExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period
The safety and tolerability of WX390 will be evaluated based on adverse events data. Other safety parameters include physical examination, clinical laboratory tests including coagulation function, renal function, hepatic function, blood glucose and blood lipid, etc.
Time frame
up to 24 weeks2
Progression-free survival rate (PFS rate)
PFS rate: is defined as the proportion of patients without objective tumor progression or death.
Time frame
up to 24 weeks3
Objective response rate (ORR)
ORR: is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1.
Time frame
up to 24 weeksSecondary outcomes
1
Progression-free survival (PFS)
PFS: is defined as the time from randomization until objective tumor progression or death, whichever occurs first.
Time frame
up to 48 weeks2
Overall survival (OS)
OS: is defined as the time from randomization until death from any cause.
Time frame
up to 48 weeks3
Disease-control rate (DCR)
DCR: is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.1.
Time frame
up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov