A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma

NCT ID: NCT06321250

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2027-04-30

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.

Conditions

Renal Cell Carcinoma Metastatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days.

Group Type: EXPERIMENTAL

JMKX003948

Intervention Type: DRUG

Subjects will receive JMKX003948 tablets until disease progression

Dose Expansion

Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days.

Group Type: EXPERIMENTAL

JMKX003948

Intervention Type: DRUG

Subjects will receive JMKX003948 tablets until disease progression

Interventions

JMKX003948

Subjects will receive JMKX003948 tablets until disease progression

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Hangyu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jemincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Guo

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Caancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Huihui Xiang

Role: CONTACT

xianghuihui@jemincare.com

+86 15928607671

Facility Contacts

Jun Guo, Master

Role: primary

Other Identifiers

JY-JM3948-101

Identifier Type: -

Identifier Source: org_study_id