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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Caancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Huihui Xiang
xianghuihui@jemincare.com
+86 15928607671
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 80
Treatments
Experimental: Dose Escalation
Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days.
Experimental: Dose Expansion
Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days.
Related Therapeutic Areas
Sponsors
Leads: Jemincare
Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd.