Advanced Solid TumorsPhase 1NCT07208136
A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors
A Phase 1 study testing JMKX005425 in people with Advanced Solid Tumors, run by Jemincare at 1 site in China.
Trial summary
This is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- JMKX005425
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2025to Dec 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documented advanced solid tumor.
- Has at least one measurable lesion per RECIST v1.1.
- Has a life expectancy of ≥ 12 weeks.
- Adequate organ function.
Who cannot join
- Toxicities from prior anti-tumor therapy has not recovered to Grade 1 or below per CTCAE v5.0.
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Has the dysphagia, or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug.
- Has the severe chronic or active infection
- Has a history of severe cardiovascular disease.
- Subject is pregnant or breastfeeding.
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 Cancer Hospital
Beijing, 100142
Lin Shen, +86 010-88196561, doctorshenlin@sina.cn
About this study
Official title: An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX005425 Tablets in Subjects With Microsatellite Instability-High or Mismatch Repair Deficient Advanced Solid Tumors
This is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- JMKX005425
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX005425Drug
JMKX005425 administered orally.
| Study group | Role | What they receive |
|---|---|---|
| JMKX005425 | Experimental | Subjects will take a pre-specified dose of JMKX005425. Receives: Drug: JMKX005425 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)
To assess the safety and tolerability of JMKX005425.
Measured: up to 2 years
Secondary outcomes (4)
maximum plasma concentration (Cmax)
Maximum observed concentration.
Measured: Up to 2 months
maximum plasma concentration (Tmax)
Time to reach maximum observed plasma concentration.
Measured: Up to 2 months
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 2 years
Disease Control Rate (DCR)
DCR is the percentage of patients with a best overall response of CR or PR or Stable Disease (SD) per RECIST v1.1.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start22 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208136
- Sponsor's protocol ID
- JMKX005425-X101
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 1 Dec 2025
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX005425 Tablets in Subjects With Microsatellite Instability-High or Mismatch Repair Deficient Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07208136
- Acronym / sponsor ID
- JMKX005425-X101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Oct 2025 (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 is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JMKX005425 | Experimental | Drug: JMKX005425Subjects will take a pre-specified dose of JMKX005425. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documented advanced solid tumor.
- Has at least one measurable lesion per RECIST v1.1.
- Has a life expectancy of ≥ 12 weeks.
- Adequate organ function.
Key exclusion criteria (6 listed)
- Toxicities from prior anti-tumor therapy has not recovered to Grade 1 or below per CTCAE v5.0.
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Has the dysphagia, or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug.
- Has the severe chronic or active infection
- Has a history of severe cardiovascular disease.
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 |
|---|---|---|
| JMKX005425JMKX005425 administered orally. | Drug | JMKX005425 |
Primary outcome
Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)
Time frame: up to 2 years
To assess the safety and tolerability of JMKX005425.
4 secondary outcomes
maximum plasma concentration (Cmax)
Time frame: Up to 2 months
maximum plasma concentration (Tmax)
Time frame: Up to 2 months
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
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 1 Dec 2025.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
Lin Shen 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 JMKX005425 in people with Advanced Solid Tumors, 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 4 inclusion and 6 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 1 Dec 2025. 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 Lu Chen (+86 17717684840, chenlu5@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs) (time frame: up to 2 years). 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 1 Dec 2025.