A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC). 2. Age ≥18 years. 3. At the escalation stage, patients should fulfill the following criteria at Screening: 1\) Participants with locally advanced or metastatic solid tumors including TNBC, ER+HER2-BC, ovarian cancer, small cell lung cancer, castrate-resistant prostate cancer (CRPC), or PDAC with KRAS mutant; Or any other locally advanced or metastatic solid tumor with evidence of deregulated RB-pathway based on available molecular test results and after sponsor review to confirm eligibility as determined with prior molecular assays performed in a CLIA-certified or equivalent laboratory. (Note: ① 0% - 1% of tumor cells expressing ER or PR as negative while ≥ 1% of tumor cells expressing ER or PR as positive on IHC staining, recommended by ASCO/CAP guideline Update 2020; negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by t