Advanced Solid Tumor CancerPhase 1NCT07809607
A Study to Evaluate YF087 in Subjects With MSI-H or dMMR Advanced Solid Tumors
A Phase 1 study testing YF087 in people with Advanced Solid Tumor Cancer, run by InventisBio Co., Ltd.
Trial summary
This is an open-label, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of YF087 in subjects with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Cancer
- What is being tested?
- YF087
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2026to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with locally advanced (unresectable) or metastatic solid tumors;
- dMMR/MSI-H status demonstrated in tumor tissue, blood, or other samples containing cancer cells or DNA;
- Subjects must have experienced disease progression after the most recent therapy for advanced disease (prior therapy must include at least one PD-1/PD-L1 inhibitor treatment).
- Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria;
- ECOG≤1
Who cannot join
- Prior treatment with a WRN inhibitor such as HRO760, RO7589831, GSK4418959 and NDI-219216;
- Prior to the first dose of study intervention, receipt of any anticancer treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational medicinal product within 14 days or 3 half-lives (whichever is shorter);
- Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis and/or brainstem metastases and/or spinal cord compression;
- Subjects with clinically significant cardiovascular and cerebrovascular disease
- Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
- Use of, or planned use of, any of the following medications that has not been discontinued for at least 14 days or 5 half-lives (whichever is shorter) before the first study drug administration:
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- Strong CYP3A4 inducers or inhibitors;
- Drugs known to prolong the QT interval.
- Pregnant or lactating females;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Multicenter, Phase I Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of YF087 in Patients With Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) Advanced Solid Tumors
This is an open-label, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of YF087 in subjects with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) advanced solid tumors.
- Conditions
- Advanced Solid Tumor Cancer
- Being tested
- YF087
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YF087Drug
Dosage form: Tablet • Administration route: Oral, once a day
| Study group | Role | What they receive |
|---|---|---|
| YF087 | Experimental | Not described Receives: Drug: YF087 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects participants with adverse events
Number of subjects participants with adverse events
Measured: From enrollment to 30 days after last dose
Subject incidence of Dose-limiting toxicities (DLT)
Measured: From enrollment to Cycle 1 Day 21
Objective response rate (ORR)
Measured: From enrollment to the end of treatment, about 1 year
Secondary outcomes (11)
Disease control rate (DCR)-assessed by IRC and investigators
Measured: From enrollment to the end of treatment, about 1 year
Progression free survival (PFS)
Measured: From enrollment to the end of treatment, about 1 year
Duration of Response (DOR)
Measured: From enrollment to the end of treatment, about 1 year
Change from baseline in QT/QTc interval
Measured: On Cycle 0 Day 1 and Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: area under the concentration-time curve from the time of dosing to time t (AUC0-t)
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Mean residence time (MRT)
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: maximum concentration (Cmax)
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Time to maximum concentration (Tmax)
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: t1/2
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Apparent Volume of Distribution (Vz/F)
Measured: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start18 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 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 Tumor CancerStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, MD, Principal investigator, Sun Yat-sen University Cancer Center (SYSUCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809607
- Sponsor's protocol ID
- YF087-101
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase I Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of YF087 in Patients With Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07809607
- Acronym / sponsor ID
- YF087-101
- Conditions
- Advanced Solid Tumor Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Sep 2026 (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 an open-label, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of YF087 in subjects with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YF087 | Experimental | Drug: YF087 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with locally advanced (unresectable) or metastatic solid tumors;
- dMMR/MSI-H status demonstrated in tumor tissue, blood, or other samples containing cancer cells or DNA;
- Subjects must have experienced disease progression after the most recent therapy for advanced disease (prior therapy must include at least one PD-1/PD-L1 inhibitor treatment).
- Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria;
- ECOG≤1
Key exclusion criteria (9 listed)
- Prior treatment with a WRN inhibitor such as HRO760, RO7589831, GSK4418959 and NDI-219216;
- Prior to the first dose of study intervention, receipt of any anticancer treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational medicinal product within 14 days or 3 half-lives (whichever is shorter);
- Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis and/or brainstem metastases and/or spinal cord compression;
- Subjects with clinically significant cardiovascular and cerebrovascular disease
- Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
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 |
|---|---|---|
| YF087Dosage form: Tablet • Administration route: Oral, once a day | Drug | YF087 |
Primary outcome
Number of subjects participants with adverse events
Time frame: From enrollment to 30 days after last dose
Number of subjects participants with adverse events
Subject incidence of Dose-limiting toxicities (DLT)
Time frame: From enrollment to Cycle 1 Day 21
Objective response rate (ORR)
Time frame: From enrollment to the end of treatment, about 1 year
11 secondary outcomes
Disease control rate (DCR)-assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, about 1 year
Progression free survival (PFS)
Time frame: From enrollment to the end of treatment, about 1 year
Duration of Response (DOR)
Time frame: From enrollment to the end of treatment, about 1 year
Change from baseline in QT/QTc interval
Time frame: On Cycle 0 Day 1 and Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: area under the concentration-time curve from the time of dosing to time t (AUC0-t)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Mean residence time (MRT)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: maximum concentration (Cmax)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Time to maximum concentration (Tmax)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: t1/2
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Apparent Volume of Distribution (Vz/F)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
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 Sep 2026.
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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.
Ruihua Xu, MD principal investigator
Sun Yat-sen University Cancer Center (SYSUCC)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YF087 in people with Advanced Solid Tumor Cancer, run by InventisBio Co., Ltd.
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 5 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yuting Li (8615821378026, yuting.li@inventisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects participants with adverse events (time frame: From enrollment to 30 days after last dose). 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 Sep 2026.