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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923515
• Other study ID #: JY-JM-0197-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

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