NCT06321250RecruitingPhase 1
A Study of JMKX003948 Tablets in 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
Source: ClinicalTrials.gov · Last updated 9 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 14 Mar 2024
- Start date
- 14 Mar 2024
- Primary completion date
- 31 May 2026
- Lead sponsor
- Jemincare
- Diseases
- Kidney cancer
- NCT number
- NCT06321250
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 80
- From 14 Mar 2024 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy.
Other illness
- Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease.
- Subjects with dysphagia or known drug absorption disorders.
- Has a history of any other malignancy within 5 years.
Other
- Patients with known active CNS metastases and/or cancerous meningitis.
- Has severe oncological complications.
- Is currently participating in other clinical studies.
- Subjects with be unsuitable for participation in the trial evaluated by investigator.
Who the study is looking for
- Has the ability to understand and willingness to sign a written informed consent form.
- Male or female from 18 years of age or older.
- Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma.
- Has at least one measurable lesion per RECIST v1.1.
- Has a life expectancy of ≥ 12 weeks.
- Adequate organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Caancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.