PIK3CA Mutation-Related TumorsPhase 1/2NCT06132932
A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations
A Phase 1/2 study testing WX390 in people with PIK3CA Mutation-Related Tumors, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PIK3CA Mutation-Related Tumors
- What is being tested?
- WX390
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2021to 3 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390, a PI3K/mTOR Dual Inhibitor, for the Treatment of Advanced Solid Tumors With PIK3CA Mutations
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.
Read the detailed description
This study is a multicenter, open-label phase Ib/IIa clinical trial for patients with advanced solid tumors who have failed standard treatment. The study adopts a basket design, divided into 6 cohorts, with a total of 70-80 advanced solid tumor patients with PIK3CA mutations enrolled. Participants will receive WX390 treatment administered continuously daily, with each cycle lasting 28 days, until disease progression or intolerable toxicity occurs. During the study, safety and efficacy will be evaluated, with efficacy assessment based on RECIST 1.1. In addition, the study will collect tumor tissue or blood samples from the participants to explore the relationship between other biomarkers and treatment efficacy, as well as the impact of changes in PIK3CA mutation status before and after treatment on efficacy.
- Conditions
- PIK3CA Mutation-Related Tumors
- Being tested
- WX390
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX390Drug
Also called WXFL10030390
Participants will receive WX390 1.1 mg tablet orally once a day for a continuous 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| WX390 | Experimental | Participants will receive WX390 continuous oral dosing (1.1 mg once a day). Receives: Drug: WX390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of WX390 in treating patients with advanced malignant solid tumors harboring PIK3CA mutations.
Safety will be evaluated by monitoring AE/SAE
Measured: 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.
Measured: From the start of the trial,up to 24 weeks
Secondary outcomes (3)
Disease Control Rate (DCR) determined according to RECIST 1.1 criteria
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.1.
Measured: From the start of the trial,up to 24 weeks
Duration of Response (DOR) determined according to RECIST 1.1 criteria
DOR is defined as the time from the initial occurrence of a complete response (CR) or partial response (PR) until disease progression or death due to any cause.
Measured: From the start of the trial,up to 24 weeks
Progression-Free Survival (PFS) determined according to RECIST 1.1 criteria
PFS is defined as the time from randomization until objective tumor progression or death, whichever occurs first.
Measured: From the start of the trial,up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start3 Jun 2021
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PIK3CA Mutation-Related TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- WX390 continuous oral dosing (1.1 mg once a day).
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, PhD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132932
- Sponsor's protocol ID
- JYA0102
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390, a PI3K/mTOR Dual Inhibitor, for the Treatment of Advanced Solid Tumors With PIK3CA Mutations
- ClinicalTrials.gov ID
- NCT06132932
- Acronym / sponsor ID
- JYA0102
- Conditions
- PIK3CA Mutation-Related Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multicenter, open-label phase Ib/IIa clinical trial for patients with advanced solid tumors who have failed standard treatment. The study adopts a basket design, divided into 6 cohorts, with a total of 70-80 advanced solid tumor patients with PIK3CA mutations enrolled. Participants will receive WX390 treatment administered continuously daily, with each cycle lasting 28 days, until disease progression or intolerable toxicity occurs. During the study, safety and efficacy will be evaluated, with efficacy assessment based on RECIST 1.1. In addition, the study will collect tumor tissue or blood samples from the participants to explore the relationship between other biomarkers and treatment efficacy, as well as the impact of changes in PIK3CA mutation status before and after treatment on efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- WX390 continuous oral dosing (1.1 mg once a day).
| Arm | Type | Receives |
|---|---|---|
| WX390 | Experimental | Drug: WX390Participants will receive WX390 continuous oral dosing (1.1 mg once a day). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WX390Also: WXFL10030390Participants will receive WX390 1.1 mg tablet orally once a day for a continuous 28-day cycle. | Drug | WX390 |
Primary outcome
Safety of WX390 in treating patients with advanced malignant solid tumors harboring PIK3CA mutations.
Time frame: From the start of the trial,up to 24 weeks
Safety will be evaluated by monitoring AE/SAE
Objective Response Rate (ORR)
Time frame: From the start of the trial,up to 24 weeks
ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1.
3 secondary outcomes
Disease Control Rate (DCR) determined according to RECIST 1.1 criteria
Time frame: From the start of the trial,up to 24 weeks
Duration of Response (DOR) determined according to RECIST 1.1 criteria
Time frame: From the start of the trial,up to 24 weeks
Progression-Free Survival (PFS) determined according to RECIST 1.1 criteria
Time frame: From the start of the trial,up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Li, PhD principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WX390 in people with PIK3CA Mutation-Related Tumors, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of WX390 in treating patients with advanced malignant solid tumors harboring PIK3CA mutations. (time frame: From the start of the trial,up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.