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

ConditionMalignant Pleural Effusions (Mpe)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJemincare

About this trial

A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant voluntarily joined the study, signed an informed consent form, and had good compliance.

Age ≥ 18 years and ≤ 75 years old, regardless of gender.

Participants with advanced solid tumors diagnosed by histopathology or cytopathology.

Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.

Disqualifiers

Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.

Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.

Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。

Known allergies to the study drug or its excipient components.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JMKX000197

    Drug

    for pleural perfusion

  • Tube thoracostomy drainage

    Procedure/Surgery

    Tube thoracostomy drainage

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm COther 1 intervention

Trial outcomes

Primary outcomes

1

AEs or SAEs

Time frame
Up to approximately 36 days
2

Recommended Phase II dose (RP2D)

Time frame
Up to approximately 24 months

Secondary outcomes

1

Puncture /drainage-Free Survival (PuFS)

Time frame
Up to approximately 24 months
2

Pleural effusion overall response (ORR)

Time frame
Up to approximately 24 months
3

Overall survival (OS)

Time frame
Up to approximately 24 months
4

Pharmacokinetics (Cmax)

Time frame
Up to approximately 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov
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