RecruitingPhase 1

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

China30 participantsStarted 2024-12-28

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

AEs or SAEs

Timeframe: Up to approximately 36 days

Recommended Phase II dose (RP2D)

Timeframe: Up to approximately 24 months

Trial details

NCT IDNCT06740019

SponsorJemincare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Fawei Wu

+86 15720614080 wufawei@jemincare.com

View on ClinicalTrials.gov More Malignant Pleural Effusions (Mpe) trials