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

NCT07809607 | Not Yet Recruiting Phase 1

• 1 other identifier: YF087-101
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Solid Tumor Cancer

Outcome Measures

Primary Outcomes (3)

• Number of subjects participants with adverse events

  Number of subjects participants with adverse events

  From enrollment to 30 days after last dose

• Subject incidence of Dose-limiting toxicities (DLT)

  From enrollment to Cycle 1 Day 21

• Objective response rate (ORR)

  From enrollment to the end of treatment, about 1 year

Secondary Outcomes (11)

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

  From enrollment to the end of treatment, about 1 year

• Progression free survival (PFS)

  From enrollment to the end of treatment, about 1 year

• Duration of Response (DOR)

  From enrollment to the end of treatment, about 1 year

• Change from baseline in QT/QTc interval

  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)

  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

  From enrollment to the end of treatment, about 1 year

Study Arms (1)

YF087

EXPERIMENTAL

Drug: YF087

Interventions

YF087 DRUG

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

YF087

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Officials

• Ruihua Xu, MD

  Sun Yat-sen University Cancer Center (SYSUCC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuting Li

CONTACT

8615821378026; yuting.li@inventisbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 9, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09