Clinical trial · Interventional
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
NCT06321250CI-TRIAL-00078669recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMKX003948 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days.
- interventionNames
- Drug: JMKX003948
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days.
- interventionNames
- Drug: JMKX003948
Primary outcomes (3)
- measure
- Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.