Solid TumorPhase 2NCT06117540
A Study of WX390 in Patients With Advanced Solid Tumors
A Phase 2 study testing WX390 in people with Solid Tumor, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are: PFS, OS, DoR at week 48; antitumor effects at week 24 and week 48. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Solid Tumor
- 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
- 70 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 12 Jun 2026
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Histological or cytological confirmed advanced solid tumor, standard regimen failed
- 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
Who cannot join
- 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
- 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
- Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
Show all 11Show fewer
- Active hepatitis B or C infection
- Inability to take medication orally
- Abuse of alcohol or drugs
- Pregnant or lactating women
- People with cognitive and psychological abnormality or with low compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Xiaohua Wu, PhD
Xiaohua Wu, PhD
About this study
Official title: An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:
- PFS, OS, DoR at week 48;
- antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.
Read the detailed description
This study will be an open-label, multicenter phase II 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 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
- Conditions
- Solid Tumor
- 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
WX390 tablet, 1.1 mg once a day
| 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.
Progression-Free Survival (PFS)
PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first.
Measured: Week 48
Overall Survival (OS)
OS, time from first dose of trial medication to death due to any cause.
Measured: Week 48
Duration of Response (DOR)
DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first.
Measured: Week 48
Progression-free survival rate (PFSR)
PFSR, Percentage of patients alive without progression from baseline.
Measured: Week 24 and Week 48
Objective Response Rate (ORR)
ORR, proportion of patients with complete response (CR) or partial response (PR).
Measured: Week 24 and Week 48
Disease control rate (DCR)
DCR, proportion of patients with CR or PR or SD.
Measured: Week 24 and Week 48
Secondary outcomes (1)
Incidence, nature, and severity of adverse events (AEs)
Incidence, nature, and severity of adverse events (AEs) refer to the frequency, type, and level of harm of undesirable effects in clinical trials. Incidence shows how often AEs occur. Nature describes the specific characteristics of AEs, while severity indicates the extent of harm caused.
Measured: Week 24 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start11 May 2021
- Primary completion12 Jun 2025 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaohua Wu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117540
- Sponsor's protocol ID
- WX390-002
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2023
- Last updated
- 19 Nov 2024
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06117540
- Acronym / sponsor ID
- WX390-002
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 12 Jun 2025 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 7 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 efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:
- PFS, OS, DoR at week 48;
- antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.
Detailed description
This study will be an open-label, multicenter phase II 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 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WX390 | Experimental | Drug: WX390Participants will receive WX390 continuous oral dosing (1.1 mg once a day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age
- Histological or cytological confirmed advanced solid tumor, standard regimen failed
- 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 (11 listed)
- 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
- 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
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: WXFL10030390WX390 tablet, 1.1 mg once a day | Drug | WX390 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Week 48
PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first.
Overall Survival (OS)
Time frame: Week 48
OS, time from first dose of trial medication to death due to any cause.
Duration of Response (DOR)
Time frame: Week 48
DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first.
Progression-free survival rate (PFSR)
Time frame: Week 24 and Week 48
PFSR, Percentage of patients alive without progression from baseline.
Objective Response Rate (ORR)
Time frame: Week 24 and Week 48
ORR, proportion of patients with complete response (CR) or partial response (PR).
Disease control rate (DCR)
Time frame: Week 24 and Week 48
DCR, proportion of patients with CR or PR or SD.
1 secondary outcome
Incidence, nature, and severity of adverse events (AEs)
Time frame: Week 24 and Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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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.
Xiaohua Wu, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WX390 in people with Solid Tumor, 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 11 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: status not confirmed, as of the sponsor's last update on 19 Nov 2024. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiajia Li (008621-64175590, doc_lijiajia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Week 48). The study lists 6 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 19 Nov 2024.