A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma

NCT06321250 | Recruiting Phase 1

• 1 other identifier: JY-JM3948-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• maximum plasma concentration (Cmax)

  Up to 1 month

• maximum plasma concentration (Tmax)

  Up to 1 month

• Duration of Response (DoR)

  Up to 1 year

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Drug: JMKX003948

Dose Expansion

EXPERIMENTAL

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

Drug: JMKX003948

Interventions

JMKX003948 DRUG

Subjects will receive JMKX003948 tablets until disease progression

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the ability to understand and willingness to sign a written informed consent form.
• Male or female from 18 years of age or older.
• Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma.
• Has at least one measurable lesion per RECIST v1.1.
• Has a life expectancy of ≥ 12 weeks.
• Adequate organ function.

You may not qualify if:

• Patients with known active CNS metastases and/or cancerous meningitis.
• 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.
• Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy.
• Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease.
• Subjects with dysphagia or known drug absorption disorders.
• Has a history of any other malignancy within 5 years.
• Has severe oncological complications.
• Is currently participating in other clinical studies.
• Subjects with be unsuitable for participation in the trial evaluated by investigator.

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Caancer Hospital

Beijing, China

RECRUITING

Study Officials

• Jun Guo

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huihui Xiang

CONTACT

+86 15928607671; xianghuihui@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)