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

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

Study Overview

• Status: Recruiting
• Conditions: Malignant Pleural Effusions (Mpe)
• Intervention / Treatment: Drug: JMKX000197; Procedure: Tube thoracostomy drainage

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fawei Wu; Phone Number: +86 15720614080; Email: wufawei@jemincare.com

Study Locations

• China
  • Beijing, China, 100017
    • Recruiting
    • Cancer Hospital, Chinese Academy of Medical Sciences
    • Contact: Ning Li; Phone Number: (+86) 010-87788165; Email: ncctrials@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
4. Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
6. Life expectancy of at least 3 months.
7. Adequate organ function.
8. 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.

Exclusion Criteria:

1. Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
2. Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
3. Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
4. Known allergies to the study drug or its excipient components.
5. Have participated in other clinical trials within 28 days prior to randomization.
6. Major surgery within 28 days prior to randomization.
7. Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
8. Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
9. 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.
10. Have a history of organ transplantation.
11. Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; JMKX000197 Dose 1	Drug: JMKX000197; for pleural perfusion
Experimental: Arm B; JMKX000197 Dose 2	Drug: JMKX000197; for pleural perfusion
Other: Arm C; Tube thoracostomy drainage	Procedure: Tube thoracostomy drainage; Tube thoracostomy drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AEs or SAEs	Up to approximately 36 days
Recommended Phase II dose (RP2D)	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Up to approximately 24 months
Puncture /drainage-Free Survival (PuFS)	Up to approximately 24 months
Pleural effusion overall response (ORR)	Up to approximately 24 months
Pharmacokinetics (Cmax)	Up to approximately 7 days
Pharmacokinetics(Tmax)	Up to approximately 7 days
Pharmacokinetics (t1/2)	Up to approximately 7 days
Pharmacokinetics (AUC0-inf)	Up to approximately 7 days
Pharmacokinetics (AUC0-t)	Up to approximately 7 days
Amount of Drug Excreted Via Urine and Excrement	Up to approximately 48 hours

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Ning Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Diseases; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: JY-JM-0197-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No