A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
ConditionMalignant Pleural Effusions (Mpe)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJemincare
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JMKX000197
- Tube thoracostomy drainage
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov