Trials / Unknown
UnknownNCT05923515
A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
A Phase I, Open, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- Jemincare · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I, Open, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Detailed description
Primary objectives: To evaluate the safety and tolerability of JMKX000197 injection in the treatment of patients with malignant pleural effusion, explore DLT of JMKX000197 treatment, and determine MTD and RP2D. Secondary objectives: To evaluate the pharmacokinetic (PK)/pharmacokinetic (PD) characteristics of JMKX000197 injection in the treatment of patients with malignant pleural effusion; To evaluate preliminarily efficacy of JMKX000197 injection in patients with malignant pleural effusion; To evaluate the drug metabolic transformation of JMKX000197 injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JMKX000197 | for injection |
Timeline
- Start date
- 2023-05-22
- Primary completion
- 2025-04-30
- Completion
- 2025-05-01
- First posted
- 2023-06-28
- Last updated
- 2023-06-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05923515. Inclusion in this directory is not an endorsement.