Renal Cell Carcinoma MetastaticPhase 1NCT06321250
A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
A Phase 1 study testing JMKX003948 in people with Renal Cell Carcinoma Metastatic, run by Jemincare at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma Metastatic
- What is being tested?
- JMKX003948
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Has severe oncological complications.
- Is currently participating in other clinical studies.
- Subjects with be unsuitable for participation in the trial evaluated by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Caancer Hospital
Beijing
Jun Guo, Master
About this study
Official 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
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
- Being tested
- JMKX003948
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003948Drug
Subjects will receive JMKX003948 tablets until disease progression
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: JMKX003948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
Number of participants with DLTs
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (3)
maximum plasma concentration (Cmax)
Maximum observed concentration.
Measured: Up to 1 month
maximum plasma concentration (Tmax)
Time to reach maximum observed plasma concentration.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start14 Mar 2024
- Primary completion31 May 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321250
- Sponsor's protocol ID
- JY-JM3948-101
- Status last verified
- Jul 2024
- First submitted
- 14 Mar 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06321250
- Acronym / sponsor ID
- JY-JM3948-101
- Conditions
- Renal Cell Carcinoma Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JMKX003948Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days. |
| Dose Expansion | Experimental | Drug: JMKX003948Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMKX003948Subjects will receive JMKX003948 tablets until disease progression | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to 2 months
Number of participants with DLTs
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.
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.
3 secondary outcomes
maximum plasma concentration (Cmax)
Time frame: Up to 1 month
maximum plasma concentration (Tmax)
Time frame: Up to 1 month
Duration of Response (DoR)
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Guo principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX003948 in people with Renal Cell Carcinoma Metastatic, run by Jemincare at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huihui Xiang (+86 15928607671, xianghuihui@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Number of participants with dose limiting toxicities (DLTs) (time frame: Up to 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.