Gastric Type Adenocarcinoma (GAS) With STK11 MutationPhase 2NCT06124963
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
A Phase 2 study testing WX390 and Toripalimab in people with Gastric Type Adenocarcinoma (GAS) With STK11 Mutation, 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 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastric Type Adenocarcinoma (GAS) With STK11 Mutation
- What is being tested?
- WX390 and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 9 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Gastric-type Endocervical Adenocarcinoma.
- 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-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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Shanghai, Shanghai Municipality, 200090
Yu Kang, PhD
Yu Kang, PhD
About this study
Official title: A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:
- Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.
- 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.
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 28-days 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.
- Being tested
- WX390, Toripalimab
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, 0.9 mg once a day
ToripalimabDrug
240 mg, Day 1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| WX390 + Toripalimab | Experimental | Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks). Receives: Drug: WX390; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate (PFS rate)
PFS rate, defined as the proportion of patients who have not experienced disease progression (PD) or death due to any cause during the study period.
Measured: up to 24 weeks
Objective response rate (ORR)
ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) confirmed by RECIST v1.1 assessment.
Measured: up to 24 weeks
Secondary outcomes (3)
Progression-free survival (PFS)
PFS, defined as the time from the first treatment to the first occurrence of disease progression or death due to any cause during the study period (whichever comes first).
Measured: up to 24 weeks
Overall survival (OS)
OS, defined as the time from the first treatment to death due to any cause.
Measured: up to 48 weeks
Time to reach plasma Cmax (Tmax) of WX390
Test the plasma drug concentration of WX390 to calculate Tmax.
Measured: 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 posted9 Nov 2023
- Study start25 Aug 2023
- Primary completion12 Dec 2025 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Type Adenocarcinoma (GAS) With STK11 MutationStudies 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
- Sequential
- Model description
- WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Kang, PhD, Principal investigator, The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124963
- Sponsor's protocol ID
- JYP0390M207
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2023
- Last updated
- 10 Dec 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
- ClinicalTrials.gov ID
- NCT06124963
- Acronym / sponsor ID
- JYP0390M207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 9 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 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:
- Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.
- 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.
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 28-days 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)
| Arm | Type | Receives |
|---|---|---|
| WX390 + Toripalimab | Experimental | Drug: WX390, Drug: ToripalimabParticipants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks). |
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 Gastric-type Endocervical Adenocarcinoma.
- 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
- 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
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, 0.9 mg once a day | Drug | WX390 + Toripalimab |
| Toripalimab240 mg, Day 1, every 3 weeks | Drug | WX390 + Toripalimab |
Primary outcome
Progression-free survival rate (PFS rate)
Time frame: up to 24 weeks
PFS rate, defined as the proportion of patients who have not experienced disease progression (PD) or death due to any cause during the study period.
Objective response rate (ORR)
Time frame: up to 24 weeks
ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) confirmed by RECIST v1.1 assessment.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 24 weeks
Overall survival (OS)
Time frame: up to 48 weeks
Time to reach plasma Cmax (Tmax) of WX390
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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.
Yu Kang, PhD principal investigator
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
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 and Toripalimab in people with Gastric Type Adenocarcinoma (GAS) With STK11 Mutation, 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: looking for participants now, as of the sponsor's last update on 10 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaoli He (008621-63453967, fcklcsyjg@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 rate (PFS rate) (time frame: 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 10 Dec 2024.