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NCT07809607
A Study to Evaluate YF087 in Subjects With MSI-H or dMMR Advanced Solid Tumors
Conditions: Advanced Solid Tumor Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 70
Sponsor: InventisBio Co., Ltd
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.
Eligibility Criteria
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:
1. Strong CYP3A4 inducers or inhibitors;
2. Drugs known to prolong the QT interval.
* Pregnant or lactating females;
Source: ClinicalTrials.gov (NCT07809607). StuddyBuddy aggregates publicly available trial information.