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Trial Title:
A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
NCT ID:
NCT05923515
Condition:
Malignant Pleural Effusion
Conditions: Official terms:
Pleural Effusion, Malignant
Pleural Effusion
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JMKX000197
Description:
for injection
Arm group label:
JMKX000197 Dose 1
Arm group label:
JMKX000197 Dose 2
Arm group label:
JMKX000197 Dose 3
Arm group label:
JMKX000197 Dose 4
Arm group label:
JMKX000197 Dose 5
Arm group label:
JMKX000197 Dose 6
Arm group label:
JMKX000197 Dose 7
Arm group label:
JMKX000197 Dose 8
Summary:
A Phase I, Open, Multicenter Clinical Study to Evaluate the Safety, Tolerance,
Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in
the Treatment of Malignant Pleural Effusion
Detailed description:
Primary objectives: To evaluate the safety and tolerability of JMKX000197 injection in
the treatment of patients with malignant pleural effusion, explore DLT of JMKX000197
treatment, and determine MTD and RP2D.
Secondary objectives: To evaluate the pharmacokinetic (PK)/pharmacokinetic (PD)
characteristics of JMKX000197 injection in the treatment of patients with malignant
pleural effusion; To evaluate preliminarily efficacy of JMKX000197 injection in patients
with malignant pleural effusion; To evaluate the drug metabolic transformation of
JMKX000197 injection.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient 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. Malignant pleural effusion confirmed by histopathology or cytopathology as moderate
or above and requiring drainage (definition of moderate pleural effusion: pleural
effusion ≥ 3cm in lying position by B-ultrasound, pleural effusion ≥ 4cm in sitting
position by B-ultrasound, accompanied by clinical symptoms such as chest tightness,
shortness of breath, and discomfort).
4. Karnofsky score ≥ 60, or physical fitness score (ECOG PS) ≤ 2.
5. Expected survival time ≥ 3 months.
6. Within 7 days before treatment, the main organ function meets the following
criteria: blood routine examination criteria (without blood transfusion within 14
days): neutrophil count ≥ 1.5 × 10 ^ 9 /L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 × 10
^ 9 /L, White blood cells ≥ 3.0 × 10 ^ 9 /L; Biochemical examination indicators
should meet: total bilirubin ≤ 1.5 × ULN, ALT≤2.5 × ULT, AST≤2.5 × ULT, if
accompanied by liver metastasis, ALT and AST ≤ 5 × ULN, Serum creatinine (Cr) ≤ 1.5
× ULN or creatinine clearance rate (CCr) ≥ 60ml/min; International normalized ratio
(INR) or prothrombin time (PT) ≤ 1.5 × ULN.
7. No intrathoracic drug injection was performed within 1 month before signing the
informed consent form, but diagnostic puncture is not excluded.
8. Women of reproductive age should agree to use contraception (such as intrauterine
devices, birth control pills, or condoms) during the study period and within 6
months after the end of the study; The serum pregnancy test was negative within 7
days before enrollment and must be a non lactating patient; Men should agree to use
effective contraception during the study period and within 6 months after the end of
the study period.
Exclusion Criteria:
1. Known allergies to the study drug or its excipient components.
2. The location of pleural effusion is not suitable for drainage or the patient will
not benefit from intrathoracic medication (e.g., severe separation).
3. Have used interferon gene stimulating factor (STING) agonists, TNF drugs (such as
Tianenfu) for thoracic injection.
4. Have participated in other clinial trials within 4 weeks before signing the informed
consent form.
5. Have a history of immunodeficiency, including a positive test for human
immunodeficiency virus (HIV) antibodies, or have other acquired or congenital
immunodeficiency diseases, or have a history of organ transplantation.
6. Uncontrollable systemic infections (viruses, bacteria, fungi), including but not
limited to hepatitis B surface antigen positive and hepatitis B virus DNA > 1000
IU/ml, hepatitis C virus (HCV) antibody positive or RNA positive.
7. According to the judgment of the researcher, the patient is not suitable for
participating in this clinical study for any reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430062
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianying Huang
Phone:
+86 18971116998
Email:
znyylcsy@126.com
Start date:
May 22, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Jemincare
Agency class:
Industry
Collaborator:
Agency:
Zhejiang Hangyu Pharmaceutical Co., Ltd
Agency class:
Other
Source:
Jemincare
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05923515
