Actively Recruiting
An Open-label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
Led by Jemincare · Updated on 2024-07-09
80
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
J
Jemincare
Lead Sponsor
Z
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of JMKX003948 tablets in patients with renal cell carcinoma. This open-label Phase 1 study focuses on patients with locally advanced or metastatic clear cell renal cell carcinoma who have measurable lesions and a life expectancy of at least 12 weeks. Participants will receive JMKX003948 tablets in treatment cycles lasting 21 days. The study includes two parts: a dose escalation phase to determine the maximum tolerated and administrable dose, followed by a dose expansion phase where subjects receive the recommended dose. Treatment continues until disease progression. During the study, researchers will monitor dose-limiting toxicities, adverse events, and serious adverse events for up to two years. They will also assess objective response rates and duration of response for up to one year. Regular evaluations will include measuring drug levels in plasma and other health assessments. Participants' safety and treatment effects will be closely observed throughout the study period.
CONDITIONS
Brief Title
A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Male or female aged 18 years or older
- Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma
- At least one measurable lesion per RECIST v1.1
- Life expectancy of at least 12 weeks
- Adequate organ function
You will not qualify if you...
- Known active central nervous system metastases or cancerous meningitis
- Received systemic anticancer monoclonal antibodies or immunosuppressants within 4 weeks prior to first dose
- Received chemotherapy, targeted therapy, or other investigational therapy within 2 weeks prior to first dose
- Not recovered from grade 2 or higher adverse event from prior anti-tumor therapy
- Impaired heart function or significant cerebrovascular or cardiovascular disease
- Dysphagia or known drug absorption disorders
- History of other malignancy within 5 years
- Severe oncological complications
- Currently participating in other clinical studies
- Deemed unsuitable for trial participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive JMKX003948 tablets in repeated 21-day cycles until disease progression or discontinuation.
Visits every 21 days for treatment assessments
Trial Site Locations
Total: 1 location
1
Beijing Caancer Hospital
Beijing, China
Actively Recruiting
Research Team
H
Huihui Xiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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