A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

Shanghai Jiatan Pharmatech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Toripalimab; Drug: WX390

Study type: Interventional

Funder types: Industry

Identifiers

NCT06117566

JYP0390M203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

WX390 0.5 mg + Toripalimab 240mg

Experimental group

Description:

Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

Treatment:

Drug: WX390

Drug: Toripalimab

WX390 0.7 mg + Toripalimab 240mg

Experimental group

Description:

Participants will receive WX390 continuous oral dosing (0.7 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

Treatment:

Drug: WX390

Drug: Toripalimab

WX390 0.9 mg + Toripalimab 240mg

Experimental group

Description:

Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

Treatment:

Drug: WX390

Drug: Toripalimab