Malignant Pleural Effusions (Mpe)Phase 1NCT06740019
A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
A Phase 1 study testing JMKX000197 and Tube thoracostomy drainage in people with Malignant Pleural Effusions (Mpe), run by Jemincare at 1 site in China.
Trial summary
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Effusions (Mpe)
- What is being tested?
- JMKX000197 and Tube thoracostomy drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2024to Nov 2026
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
- Age ≥ 18 years and ≤ 75 years old, regardless of gender.
- Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
- Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
- Life expectancy of at least 3 months.
- Adequate organ function.
- Female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of JMKX000197. The serum pregnancy test result should be negative 7 days before enrollment and must be a non-lactating participant. Male participants must agree to use effective contraception during the study and for 6 months after discontinuation of JMKX000197.
Who cannot join
- Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
- Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
- Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
- Known allergies to the study drug or its excipient components.
- Have participated in other clinical trials within 28 days prior to randomization.
- Major surgery within 28 days prior to randomization.
Show all 11Show fewer
- Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
- Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
- Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to positive HBsAg and HBV DNA, positive HCV RNA, positive HIV antibody test or combined infections within the first 28 days of randomization and require systemic anti-infective treatment.
- Have a history of organ transplantation.
- Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100017
Ning Li, (+86) 010-87788165, ncctrials@cicams.ac.cn
About this study
Official title: A Phase Ib, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
- Conditions
- Malignant Pleural Effusions (Mpe)
- Being tested
- JMKX000197, Tube thoracostomy drainage
- Medical subject headings
- Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX000197Drug
for pleural perfusion
Tube thoracostomy drainageProcedure or surgery
Tube thoracostomy drainage
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | JMKX000197 Dose 1 Receives: Drug: JMKX000197 |
| Arm B | Experimental | JMKX000197 Dose 2 Receives: Drug: JMKX000197 |
| Arm C | Other | Tube thoracostomy drainage Receives: Procedure: Tube thoracostomy drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs or SAEs
Measured: Up to approximately 36 days
Recommended Phase II dose (RP2D)
Measured: Up to approximately 24 months
Secondary outcomes (9)
Puncture /drainage-Free Survival (PuFS)
Measured: Up to approximately 24 months
Pleural effusion overall response (ORR)
Measured: Up to approximately 24 months
Overall survival (OS)
Measured: Up to approximately 24 months
Pharmacokinetics (Cmax)
Measured: Up to approximately 7 days
Pharmacokinetics(Tmax)
Measured: Up to approximately 7 days
Pharmacokinetics (t1/2)
Measured: Up to approximately 7 days
Pharmacokinetics (AUC0-inf)
Measured: Up to approximately 7 days
Pharmacokinetics (AUC0-t)
Measured: Up to approximately 7 days
Amount of Drug Excreted Via Urine and Excrement
Measured: Up to approximately 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start28 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Effusions (Mpe)Studies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740019
- Sponsor's protocol ID
- JY-JM-0197-102
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT06740019
- Acronym / sponsor ID
- JY-JM-0197-102
- Conditions
- Malignant Pleural Effusions (Mpe)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Dec 2024 (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.
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: JMKX000197JMKX000197 Dose 1 |
| Arm B | Experimental | Drug: JMKX000197JMKX000197 Dose 2 |
| Arm C | Other | Procedure: Tube thoracostomy drainageTube thoracostomy drainage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
- Age ≥ 18 years and ≤ 75 years old, regardless of gender.
- Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
- Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
Key exclusion criteria (11 listed)
- Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
- Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
- Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
- Known allergies to the study drug or its excipient components.
- Have participated in other clinical trials within 28 days prior to randomization.
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 |
|---|---|---|
| JMKX000197for pleural perfusion | Drug | Arm A, Arm B |
| Tube thoracostomy drainageTube thoracostomy drainage | Procedure or surgery | Arm C |
Primary outcome
AEs or SAEs
Time frame: Up to approximately 36 days
Recommended Phase II dose (RP2D)
Time frame: Up to approximately 24 months
9 secondary outcomes
Puncture /drainage-Free Survival (PuFS)
Time frame: Up to approximately 24 months
Pleural effusion overall response (ORR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
Pharmacokinetics (Cmax)
Time frame: Up to approximately 7 days
Pharmacokinetics(Tmax)
Time frame: Up to approximately 7 days
Pharmacokinetics (t1/2)
Time frame: Up to approximately 7 days
Pharmacokinetics (AUC0-inf)
Time frame: Up to approximately 7 days
Pharmacokinetics (AUC0-t)
Time frame: Up to approximately 7 days
Amount of Drug Excreted Via Urine and Excrement
Time frame: Up to approximately 48 hours
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 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Effusions (Mpe)
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
RecruitingEarly Phase 1
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruitingPhase 2
Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion
Lung Cancer (NSCLC), Malignant Pleural Effusions (Mpe)- Pleurodesis
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.
Ning Li principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX000197 and Tube thoracostomy drainage in people with Malignant Pleural Effusions (Mpe), run by Jemincare 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 8 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 4 Apr 2025. 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 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.
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 Fawei Wu (+86 15720614080, wufawei@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs or SAEs (time frame: Up to approximately 36 days). 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 4 Apr 2025.