JMKX000197 Injection for Malignant Pleural Effusion
A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Recruiting
Phase 1Interventional Study
Malignant Pleural Effusions (Mpe)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Jemincare · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 75 who have advanced solid tumors and issues with fluid around the lungs that need drainage. Participants will receive JMKX000197 Injection and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
Rules you outBilateral pleural effusionCentral nervous system metastatic diseaseUncontrollable systemic infections
You may be able to join if
I am between 18 and 75 years old.
I have advanced solid tumors.
I have malignant pleural effusion confirmed by a medical test.
I can expect to live at least 3 more months.
I have good organ function.
I can comply with the study requirements.
I will agree to use contraception if I can become pregnant.
I am not pregnant or breastfeeding.
You may not be able to join if
I have fluid around both lungs or other body cavities.
I have had major surgery in the past 28 days.
I have used certain specific treatments for pleural effusion recently.
I have serious infections that need treatment.
I have central nervous system diseases or complications.
I have uncontrolled health issues affecting my heart, lungs, liver, or kidneys.
I have a history of organ transplantation.
I do not meet the study doctor's assessment of suitability.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
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Eligibility Criteria
Inclusion Criteria:
1. The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
4. Malignant pleural ef…
Inclusion Criteria:
1. The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
4. Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
6. Life expectancy of at least 3 months.
7. Adequate organ function.
8. 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.
Exclusion Criteria:
1. Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
2. Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
3. Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
4. Known allergies to the study drug or its excipient components.
5. Have participated in other clinical trials within 28 days prior to randomization.
6. Major surgery within 28 days prior to randomization.
7. Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
8. Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
9. 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.
10. Have a history of organ transplantation.
11. Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
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