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Recruiting NCT06740019

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

Phase I Interventional Malignant Pleural Effusions (Mpe)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JMKX000197, Tube thoracostomy drainage.
Who it may be relevant to
Registry conditions: Malignant Pleural Effusions (Mpe). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

Interventions

  • Drug JMKX000197
    for pleural perfusion
  • Procedure Tube thoracostomy drainage
    Tube thoracostomy drainage

Primary outcome measures

  • AEs or SAEs [Time frame: Up to approximately 36 days]
  • Recommended Phase II dose (RP2D) [Time frame: Up to approximately 24 months]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06740019 · JY-JM-0197-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗