🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06740019
Recruiting Phase 1

A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

NCT06740019 · tracked via the Priya Life Science China tracker
Sponsor
Jemincare
Phase
Phase 1
Started
2024-12-28
Last updated
2025-04-04

Condition(s) studied

Malignant Pleural Effusions (Mpe)

Investigational drug(s) / intervention(s)

JMKX000197Tube thoracostomy drainage

JMKX000197: for pleural perfusion

Tube thoracostomy drainage: Tube thoracostomy drainage

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting

More Jemincare trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740019 on ClinicalTrials.gov ↗ ← All trials in China