NCT06321250 A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
| NCT ID | NCT06321250 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jemincare |
| Condition | Renal Cell Carcinoma Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-03-14 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.
Eligibility 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.
Contact & Investigator
Jun Guo
PRINCIPAL INVESTIGATOR
Peking University Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT06321250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06321250 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06321250 currently recruiting?
Yes, NCT06321250 is actively recruiting participants. Contact the research team at xianghuihui@jemincare.com for enrollment information.
Where is the NCT06321250 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06321250 clinical trial?
NCT06321250 is sponsored by Jemincare. The principal investigator is Jun Guo at Peking University Cancer Hospital & Institute. The trial plans to enroll 80 participants.