A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. The main questions it aims to answer are: * What is the safety profile of JYP0035 when administered to these patients? * How does JYP0035 capsule behave in the body pharmacokinetically? Participants will: * Receive escalating doses of JYP0035 capsule during the dose-escalation phase (PART-1). * Continue with the identified dose in the dose-expansion phase (PART-2). As this is a single-arm study, there is no comparison group.
Eligibility Criteria
Inclusion Criteria: * Patients voluntarily participate in the clinical trial and sign the informed consent form * Age 18 years and above (inclusive), and below 75 years of age (inclusive), with no gender restrictions * ECOG(Eastern Cooperative Oncology Group)performance status of 0 or 1 * Expected survival time of ≥3 months * During the screening period, female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of the study drug * Participants agree to use reliable contraception methods from signing the informed consent form until 6 months after the last dose of the study drug. This includes, but is not limited to: abstinence, vasectomy in males, female sterilization, effective intrauterine devices, and effective contraceptive medications Exclusion Criteria: * Participants have not recovered to normal or ≤ Grade 1 from any adverse events and/or complications caused by any previous treatments before the first administration