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

NCT ID: NCT05923515

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2025-05-01

Brief 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.

Conditions

Malignant Pleural Effusion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JMKX000197 Dose 1

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 2

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 3

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 4

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 5

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 6

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 7

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

JMKX000197 Dose 8

eight dose levels of JMKX000197 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.

Group Type: EXPERIMENTAL

JMKX000197

Intervention Type: DRUG

for injection

Interventions

JMKX000197

for injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Hangyu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jemincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianying Huang

Role: PRINCIPAL_INVESTIGATOR

Zhongnan Hospital of Wuhan University，No. 169, Donghu Road, Wuchang District, Wuhan, Hubei

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

jianping Su

Role: CONTACT

sujianping@jemincare.com

+86 15162481262

Facility Contacts

Jianying Huang

Role: primary

znyylcsy@126.com

+86 18971116998

Other Identifiers

JY-JM-0197-101

Identifier Type: -

Identifier Source: org_study_id