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

NCT05923515 | Unknown Phase 1

• 1 other identifier: JY-JM-0197-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (3)

• Incidence of dose limiting toxicity

  Up to approximately 7 days at each dose level

• Maximum tolerated dose

  Up to approximately 24 months

• Recommended Phase II dose

  Up to approximately 24 months

Secondary Outcomes (9)

• Objective Response Rate（ORR）

  Up to approximately 36 days

• Disease control rate, DCR

  Up to approximately 36 days

• Maximum observed concentration (Cmax) of JMKX000197

  Up to approximately 7 days

• Time to maximum concentration (Tmax) of JMKX000197

  Up to approximately 7 days

• Half-life (t1/2) of JMKX000197

  Up to approximately 7 days

Study Arms (8)

JMKX000197 Dose 1

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 2

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 3

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 4

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 5

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 6

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 7

EXPERIMENTAL

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.

Drug: JMKX000197

JMKX000197 Dose 8

EXPERIMENTAL

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.

Drug: JMKX000197

Interventions

JMKX000197 DRUG

for injection

JMKX000197 Dose 1; JMKX000197 Dose 2; JMKX000197 Dose 3; JMKX000197 Dose 4; JMKX000197 Dose 5; JMKX000197 Dose 6; JMKX000197 Dose 7; JMKX000197 Dose 8

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient voluntarily joined the study, signed an informed consent form, and had good compliance.
• Age ≥ 18 years and ≤ 75 years old, regardless of gender.
• 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).
• Karnofsky score ≥ 60, or physical fitness score (ECOG PS) ≤ 2.
• Expected survival time ≥ 3 months.
• 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.
• No intrathoracic drug injection was performed within 1 month before signing the informed consent form, but diagnostic puncture is not excluded.
• 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.

You may not qualify if:

• Known allergies to the study drug or its excipient components.
• The location of pleural effusion is not suitable for drainage or the patient will not benefit from intrathoracic medication (e.g., severe separation).
• Have used interferon gene stimulating factor (STING) agonists, TNF drugs (such as Tianenfu) for thoracic injection.
• Have participated in other clinial trials within 4 weeks before signing the informed consent form.
• 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.
• 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.
• According to the judgment of the researcher, the patient is not suitable for participating in this clinical study for any reason.

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Jianying Huang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianping Su

CONTACT

+86 15162481262; sujianping@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 28, 2023
• Study Start: May 22, 2023
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)