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NCT Number: NCT07809607

A Study to Evaluate YF087 in Subjects With MSI-H or 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

YF087

Drug

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

Primary outcomes

  1. Number of subjects participants with adverse events

    Time frame: From enrollment to 30 days after last dose

    Number of subjects participants with adverse events

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Yuting Li

CONTACT

[email protected]

8615821378026

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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