NCT06740019 A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
| NCT ID | NCT06740019 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jemincare |
| Condition | Malignant Pleural Effusions (Mpe) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-12-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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 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.
Contact & Investigator
Ning Li
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06740019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Malignant Pleural Effusions (Mpe). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06740019 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06740019 currently recruiting?
Yes, NCT06740019 is actively recruiting participants. Contact the research team at wufawei@jemincare.com for enrollment information.
Where is the NCT06740019 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06740019 clinical trial?
NCT06740019 is sponsored by Jemincare. The principal investigator is Ning Li at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 30 participants.