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Trial Title:
A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
NCT ID:
NCT06321250
Condition:
Renal Cell Carcinoma Metastatic
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JMKX003948
Description:
Subjects will receive JMKX003948 tablets until disease progression
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Caancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, Master
Start date:
March 14, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Jemincare
Agency class:
Industry
Collaborator:
Agency:
Zhejiang Hangyu Pharmaceutical Co., Ltd
Agency class:
Other
Source:
Jemincare
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06321250
