A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma

Phase 1

Recruiting

• Conditions: Renal Cell Carcinoma Metastatic
• Interventions: Drug: JMKX003948

• Registration Number: NCT06321250
• Lead Sponsor: Jemincare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-14
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Primary Completion: 2026-05-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Expansion	JMKX003948	Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days.
Dose Escalation	JMKX003948	Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days.

Primary Outcome Measures

Name	Time	Method
Dose Escalation: Number of participants with dose limiting toxicities (DLTs)	Up to 2 months	Number of participants with DLTs
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Up to 2 years	Number of participants with AEs/SAEs to characterize the safety and tolerability of JMKX003948.
Dose Expansion: Objective Response Rate (ORR)	Up to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
maximum plasma concentration (Cmax)	Up to 1 month	Maximum observed concentration.
maximum plasma concentration (Tmax)	Up to 1 month	Time to reach maximum observed plasma concentration.
Duration of Response (DoR)	Up to 1 year	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.

Trial Locations

Locations (1)

Beijing Caancer Hospital; 🇨🇳 Beijing, China