Evaluating JMKX003948 Tablets for Patients with Renal Cell Carcinoma
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
This study is testing a new tablet called JMKX003948 to see if it is safe and effective for people with advanced kidney cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jemincare Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06321250 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX003948 tablets in patients diagnosed with metastatic renal cell carcinoma. Participants will receive the investigational drug and undergo monitoring to evaluate their response and any potential side effects. The study is designed to gather essential data that could inform future phases of development for this treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma and at least one measurable lesion.
Not a fit: Patients with active CNS metastases, significant heart or cerebrovascular disease, or those who have recently undergone certain cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic renal cell carcinoma.
How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for renal cell carcinoma have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Has the ability to understand and willingness to sign a written informed consent form. 2. Male or female from 18 years of age or older. 3. Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma. 4. Has at least one measurable lesion per RECIST v1.1. 5. Has a life expectancy of ≥ 12 weeks. 6. Adequate organ function. Exclusion Criteria: 1. Patients with known active CNS metastases and/or cancerous meningitis. 2. Has received any type of systemic anticancer monoclonal antibodies or other immunosuppressants within 4 weeks prior to the first dose. Has received prior chemotherapy, targeted therapy, or other investigational therapy within 2 weeks prior to the first dose. 3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy. 4. Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease. 5. Subjects with dysphagia or known drug absorption disorders. 6. Has a history of any other malignancy within 5 years. 7. Has severe oncological complications. 8. Is currently participating in other clinical studies. 9. Subjects with be unsuitable for participation in the trial evaluated by investigator.
Where this trial is running
Beijing
- Beijing Caancer Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Jun Guo — Peking University Cancer Hospital & Institute
- Study coordinator: Huihui Xiang
- Email: xianghuihui@jemincare.com
- Phone: +86 15928607671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.