A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
ConditionRenal Cell Carcinoma Metastatic
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
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
Qualifiers
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.
Disqualifiers
Patients with known active CNS metastases and/or cancerous meningitis.
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.
Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease.
Trial design
Treatments tested in this trial
- JMKX003948
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jemincare
Lead sponsor
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov