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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Cell Carcinoma Metastatic
• Intervention / Treatment: Drug: JMKX003948

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huihui Xiang; Phone Number: +86 15928607671; Email: xianghuihui@jemincare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: JMKX003948; Subjects will receive JMKX003948 tablets until disease progression
Experimental: Dose Expansion; Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days.	Drug: JMKX003948; Subjects will receive JMKX003948 tablets until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation: Number of participants with dose limiting toxicities (DLTs)	Number of participants with DLTs	Up to 2 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum plasma concentration (Cmax)	Maximum observed concentration.	Up to 1 month
maximum plasma concentration (Tmax)	Time to reach maximum observed plasma concentration.	Up to 1 month
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

Collaborators and Investigators

• Sponsor: Jemincare
• Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Jun Guo, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 28, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: JY-JM3948-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No