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NCT Number: NCT06321250

A Study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Caancer Hospital

Beijing, China

Location status: Recruiting

Location contact

Jun Guo, Master

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

JMKX003948

Drug

Subjects will receive JMKX003948 tablets until disease progression

Primary outcomes

  1. Dose Escalation: Number of participants with dose limiting toxicities (DLTs)

    Time frame: Up to 2 months

    Number of participants with DLTs

  2. Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 2 years

    Number of participants with AEs/SAEs to characterize the safety and tolerability of JMKX003948.

  3. Dose Expansion: Objective Response Rate (ORR)

    Time frame: 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 outcomes

  1. maximum plasma concentration (Cmax)

    Time frame: Up to 1 month

    Maximum observed concentration.

  2. maximum plasma concentration (Tmax)

    Time frame: Up to 1 month

    Time to reach maximum observed plasma concentration.

  3. Duration of Response (DoR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huihui Xiang

CONTACT

[email protected]

+86 15928607671

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Collaborators

  • Zhejiang Hangyu Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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