A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma

Renal Cell Carcinoma Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321250
• Other study ID #: JY-JM3948-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 28, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: Jemincare
• Contact: Huihui Xiang
• Phone: +86 15928607671
• Email: xianghuihui[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma Metastatic

Intervention

Drug:
• JMKX003948
Subjects will receive JMKX003948 tablets until disease progression

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jemincare	Zhejiang Hangyu Pharmaceutical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Escalation: Number of participants with dose limiting toxicities (DLTs)	Number of participants with DLTs	Up to 2 months
Primary	Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Number of participants with AEs/SAEs to characterize the safety and tolerability of JMKX003948.	Up to 2 years
Primary	Dose Expansion: Objective Response Rate (ORR)	ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 1 year
Secondary	maximum plasma concentration (Cmax)	Maximum observed concentration.	Up to 1 month
Secondary	maximum plasma concentration (Tmax)	Time to reach maximum observed plasma concentration.	Up to 1 month
Secondary	Duration of Response (DoR)	DoR is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.	Up to 1 year