ClinicalTrials.gg
Not yet recruitingNCT07809607Updated Sep 9, 2026

A Study to Evaluate YF087 in Subjects With MSI-H or dMMR Advanced Solid Tumors

A Phase 1 interventional study of YF087 in Advanced Solid Tumor Cancer, sponsored by InventisBio Co., Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by InventisBio Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumor Cancer
03

In context

Lead sponsor

InventisBio Co., Ltd is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with locally advanced (unresectable) or 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-L1 inhibitor treatment).
  • Presence of at least 1 that can be measured by CT or MRI based on V1.1 criteria;
  • ≤1

Exclusion criteria

Exclusion Criteria:

  • 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 medicinal product within 14 days or 3 half-lives (whichever is shorter);
  • Subjects with unstable or symptomatic or progressive central nervous system (CNS) and/or and/or brainstem metastases and/or spinal cord compression;
  • Subjects with 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:

    1. Strong inducers or inhibitors;
    2. Drugs known to prolong the .
  • Pregnant or lactating females;
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    YF087

    Drug: YF087

Interventions

  • DrugYF087

    Dosage form: Tablet • Administration route: Oral, once a day

06

What researchers measure

Primary outcomes

  1. Number of subjects participants with adverse events

    Number of subjects participants with adverse events

    Time frame: From enrollment to 30 days after last dose

  2. Subject incidence of Dose-limiting toxicities (DLT)

    Time frame: From enrollment to Cycle 1 Day 21

  3. Objective response rate (ORR)

    Time frame: From enrollment to the end of treatment, about 1 year

Secondary outcomes

  1. Disease control rate (DCR)-assessed by IRC and investigators

    Time frame: From enrollment to the end of treatment, about 1 year

  2. Progression free survival (PFS)

    Time frame: From enrollment to the end of treatment, about 1 year

  3. Duration of Response (DOR)

    Time frame: From enrollment to the end of treatment, about 1 year

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Other outcomes

  1. Change from baseline in concentration and/or mutations in ctDNA

    Time frame: From enrollment to the end of treatment, about 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07809607
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 18, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Yuting Li
Contact
yuting.li@inventisbio.com
8615821378026
Ruihua Xu, MD
principal investigator · Sun Yat-sen University Cancer Center (SYSUCC)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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