A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations

NCT06132932 | Completed Phase 1

• 1 other identifier: JYA0102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 in patients with advanced solid tumors. The main question it aims to answer is: • safety and preliminary efficacy in WX390 therapy. Participants will be treated with WX390 orally and follow the efficacy and safety evaluation according to the protocol.

Conditions

PIK3CA Mutation-Related Tumors

Outcome Measures

Primary Outcomes (2)

• Safety of WX390 in treating patients with advanced malignant solid tumors harboring PIK3CA mutations.

  Safety will be evaluated by monitoring AE/SAE

  From the start of the trial,up to 24 weeks

• 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.

  From the start of the trial,up to 24 weeks

Secondary Outcomes (3)

• Disease Control Rate (DCR) determined according to RECIST 1.1 criteria

  From the start of the trial,up to 24 weeks

• Duration of Response (DOR) determined according to RECIST 1.1 criteria

  From the start of the trial,up to 24 weeks

• Progression-Free Survival (PFS) determined according to RECIST 1.1 criteria

  From the start of the trial,up to 24 weeks

Study Arms (1)

WX390

EXPERIMENTAL

Participants will receive WX390 continuous oral dosing (1.1 mg once a day).

Drug: WX390

Interventions

WX390 DRUG

Participants will receive WX390 1.1 mg tablet orally once a day for a continuous 28-day cycle.

Also known as: WXFL10030390

WX390

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Histologically or cytologically confirmed advanced malignant solid tumors (excluding non-small cell lung cancer) who have failed standard treatment, have no standard treatment options, or for whom standard treatment is not suitable at the current stage (colorectal cancer patients must provide genetic test results confirming KRAS wild-type)
• 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 organic function
• Signed and dated informed consent

You may not qualify if:

• Anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy received within 4 weeks before the first use of the study drug
• Other unapproved clinical trial drugs or treatments received within 4 weeks before the first use of the study drug
• Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first use of the study drug
• Systemic use of corticosteroids or other immunosuppressive agents within 14 days before the first use of the study drug
• Previous treatment with PI3K, AKT, or mTOR inhibitors
• Active infection requiring systemic anti-infection treatment
• Known alcohol or drug dependence
• Individuals with mental disorders or poor compliance
• Pregnant or lactating women
• The researcher believes that the subject has other serious systemic medical history or other reasons that make them unsuitable for participating in this clinical study

Sponsors & Collaborators

• Shanghai Jiatan Pharmatech Co., Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 310000, China

Location

Study Officials

• Jin Li, PhD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: WX390 continuous oral dosing (1.1 mg once a day).

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 15, 2023
• Study Start: June 3, 2021
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-10

Locations

CN (1)