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Clinical trial

A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

ID
Name
JYP0390M203
Description
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.
Trial arms
Trial start
2022-11-18
Estimated PCD
2025-03-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
WX390
WX390 tablet, once a day
Arms:
WX390 0.5 mg + Toripalimab 240mg, WX390 0.7 mg + Toripalimab 240mg, WX390 0.9 mg + Toripalimab 240mg
Other names:
WXFL10030390
Toripalimab
240 mg, Day 1, every 3 weeks
Arms:
WX390 0.5 mg + Toripalimab 240mg, WX390 0.7 mg + Toripalimab 240mg, WX390 0.9 mg + Toripalimab 240mg
Size
100
Primary endpoint
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period
up to 24 weeks
Progression-free survival rate (PFS rate)
up to 24 weeks
Objective response rate (ORR)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-11-07

1 organization

2 products

1 abstract

1 indication

Organization
Shanghai Jiatan Pharmatech
Product
WX390
Indication
Solid Tumor
Product
Toripalimab
Abstract
Phase Ib study of a high potent PI3K-mTOR dual inhibitor WX390 combined with toripalimab in patients with advanced solid tumors.
Org: Department of Gynecologic Oncology, Gynecology and Obstetrics Center, The First Hospital of Jilin University, Changchun, China, Phase I Clinical Research Center, The First Hospital of Jilin University, Changchun, China, The First Hospital of Jilin University, Changchun, Jilin Province, China, Shanghai Jiatan Pharmatech CO., LTD., Shanghai, Shanghai, China, Shanghai Jiatan Pharmatech CO., LTD., Shanghai, China,