A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion

NCT07649369 | Not Yet Recruiting Phase 2

• 1 other identifier: JMKX000197-MPE201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.

Conditions

Malignant Pleural Effusions (Mpe)

Outcome Measures

Primary Outcomes (1)

• Puncture/drainage - Free Survival (PuFS)

  From the date of chest tube removal after the last dose of treatment until the date of next puncture /drainage or date of death from any cause, whichever come first, up to approximately 24 months

Secondary Outcomes (3)

• Pleural effusion overall response (ORR)

  Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months

• AEs or SAEs

  Up to approximately 29 days

Study Arms (3)

Arm A

EXPERIMENTAL

JMKX000197

Drug: JMKX000197

Arm B

EXPERIMENTAL

JMKX000197

Drug: JMKX000197

Arm C

ACTIVE COMPARATOR

Cisplatin

Drug: Cisplatin

Interventions

JMKX000197 DRUG

Intrapleural administration

Arm A; Arm B

Cisplatin DRUG

Intrapleural administration

Arm C

Eligibility Criteria

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

You may qualify if:

• Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
• Moderate to large pleural effusions require intervention.
• ECOG performance status: 0 to 2.
• Life expectancy ≥ 3 months
• Adequate organ function.
• The serum pregnancy test of female participants of childbearing potential should be negative within 7 days prior to enrollment and must not be breastfeeding. With a fertile female/male must agree to use medically accepted non-pharmacological contraception during the study and for 6 months after the last dose.

You may not qualify if:

• 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.
• Known allergies to the study drug or its excipient components.
• Have participated in other clinical trials within 28 days prior to randomization.
• Major surgery within 28 days prior to randomization.
• Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
• Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
• Active infections that require systemic treatment.
• Have a history of organ transplantation.
• Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.

Sponsors & Collaborators

• Shanghai Jeyou Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100017, China

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Myeloproliferative Disorder, Chronic, with Eosinophilia

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jie Wang

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujia Song

CONTACT

+8615640506016; songyujia@jeyoupharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)