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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.

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Conditions studied

  • Advanced Solid Tumor Cancer
03

Who can participate

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

Inclusion criteria

  • 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

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 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:

    1. Strong CYP3A4 inducers or inhibitors;
    2. Drugs known to prolong the QT interval.
  • Pregnant or lactating females;
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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

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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

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07809607
Lead sponsor
InventisBio Co., Ltd
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 ↗

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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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