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

NCT06740019 | Recruiting Phase 1

• 1 other identifier: JY-JM-0197-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Pleural Effusions (Mpe)

Outcome Measures

Primary Outcomes (2)

• AEs or SAEs

  Up to approximately 36 days

• Recommended Phase II dose (RP2D)

  Up to approximately 24 months

Secondary Outcomes (9)

• Puncture /drainage-Free Survival (PuFS)

  Up to approximately 24 months

• Pleural effusion overall response (ORR)

  Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months

• Pharmacokinetics (Cmax)

  Up to approximately 7 days

• Pharmacokinetics(Tmax)

  Up to approximately 7 days

Study Arms (3)

Arm A

EXPERIMENTAL

JMKX000197 Dose 1

Drug: JMKX000197

Arm B

EXPERIMENTAL

JMKX000197 Dose 2

Drug: JMKX000197

Arm C

OTHER

Tube thoracostomy drainage

Procedure: Tube thoracostomy drainage

Interventions

JMKX000197 DRUG

for pleural perfusion

Arm A; Arm B

Tube thoracostomy drainage PROCEDURE

Tube thoracostomy drainage

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:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
• Life expectancy of at least 3 months.
• Adequate organ function.
• Female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of JMKX000197. The serum pregnancy test result should be negative 7 days before enrollment and must be a non-lactating participant. Male participants must agree to use effective contraception during the study and for 6 months after discontinuation of JMKX000197.

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.
• Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
• 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.
• Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to positive HBsAg and HBV DNA, positive HCV RNA, positive HIV antibody test or combined infections within the first 28 days of randomization and require systemic anti-infective 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

• Jemincare: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100017, China

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Ning Li

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fawei Wu

CONTACT

+86 15720614080; wufawei@jemincare.com

Study Design

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

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: December 28, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)