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Malignant Pleural EffusionPhase 1NCT05923515

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

A Phase 1 study testing JMKX000197 in people with Malignant Pleural Effusion, run by Jemincare at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Pleural Effusion
What is being tested?
JMKX000197
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
22 May 2023to 1 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

jianping Su contact

+86 15162481262

sujianping@jemincare.com

China1 site, 1 recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430062

    Jianying Huang, +86 18971116998, znyylcsy@126.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
JMKX000197
Medical subject headings
Pleural Effusion, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JMKX000197Drug

    for injection

Study groups in NCT05923515
Study groupRoleWhat they receive
JMKX000197 Dose 1Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 2Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 3Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 4Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 5Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 6Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 7Experimentaleight 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.
Receives: Drug: JMKX000197
JMKX000197 Dose 8Experimentaleight 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.
Receives: Drug: JMKX000197

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicity

    Measured: Up to approximately 7 days at each dose level

  2. Maximum tolerated dose

    Measured: Up to approximately 24 months

  3. Recommended Phase II dose

    Measured: Up to approximately 24 months

Secondary outcomes (9)

  1. Objective Response Rate（ORR）

    Measured: Up to approximately 36 days

  2. Disease control rate, DCR

    Measured: Up to approximately 36 days

  3. Maximum observed concentration (Cmax) of JMKX000197

    Measured: Up to approximately 7 days

  4. Time to maximum concentration (Tmax) of JMKX000197

    Measured: Up to approximately 7 days

  5. Half-life (t1/2) of JMKX000197

    Measured: Up to approximately 7 days

  6. Areas under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of JMKX000197

    Measured: Up to approximately 7 days

  7. Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of JMKX000197

    Measured: Up to approximately 7 days

  8. Amount of Drug Excreted Via Urine and excrement During the Collection Interval 0-48 Hours Post Administration

    Measured: Up to approximately 48 hours

  9. Concentrations of IL-6 in plasma

    Measured: Up to approximately 36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start22 May 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923515
Sponsor's protocol ID
JY-JM-0197-101
Status last verified
Jun 2023
First submitted
23 May 2023
Last updated
28 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JMKX000197 in people with Malignant Pleural Effusion, run by Jemincare at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact jianping Su (+86 15162481262, sujianping@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicity (time frame: Up to approximately 7 days at each dose level). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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