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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05923515
Other study ID # JY-JM-0197-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 22, 2023
Est. completion date May 1, 2025

Study information

Verified date June 2023
Source Jemincare
Contact jianping Su
Phone +86 15162481262
Email sujianping@jemincare.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date May 1, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
JMKX000197
for injection

Locations

Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Jemincare Zhejiang Hangyu Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose limiting toxicity Up to approximately 7 days at each dose level
Primary Maximum tolerated dose Up to approximately 24 months
Primary Recommended Phase II dose Up to approximately 24 months
Secondary Objective Response Rate(ORR) Up to approximately 36 days
Secondary Disease control rate, DCR Up to approximately 36 days
Secondary Maximum observed concentration (Cmax) of JMKX000197 Up to approximately 7 days
Secondary Time to maximum concentration (Tmax) of JMKX000197 Up to approximately 7 days
Secondary Half-life (t1/2) of JMKX000197 Up to approximately 7 days
Secondary Areas under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of JMKX000197 Up to approximately 7 days
Secondary Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of JMKX000197 Up to approximately 7 days
Secondary Amount of Drug Excreted Via Urine and excrement During the Collection Interval 0-48 Hours Post Administration Up to approximately 48 hours
Secondary Concentrations of IL-6 in plasma Up to approximately 36 days
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