Evaluating JMKX003948 Tablets for Patients with Renal Cell Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.