A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
ConditionRenal Cell Carcinoma Metastatic
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
JMKX003948
DrugSubjects will receive JMKX003948 tablets until disease progression
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
Number of participants with DLTs
Time frame
Up to 2 months2
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.
Time frame
Up to 2 years3
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.
Time frame
Up to 1 yearSecondary outcomes
1
maximum plasma concentration (Cmax)
Maximum observed concentration.
Time frame
Up to 1 month2
maximum plasma concentration (Tmax)
Time to reach maximum observed plasma concentration.
Time frame
Up to 1 month3
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.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jemincare
Lead sponsor
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov