A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: JYP0035 Experimental Drug Treatment


Participation Criteria
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Eligibility Criteria
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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 of the study drug, excluding hair loss and pigmentation Patients with imaging (CT or MRI) showing tumor invasion into major blood vessels (such as the aorta, pulmonary arteries and veins, vena cava, etc.) Patients who have had clinically significant cardiovascular or cerebrovascular diseases within 6 months before the first administration, which, in the investigator's judgment, may interfere with the patient's full participation in the study; atrial fibrillation; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention Patients who had history of type 1 diabetes, type 2 diabetes, or gestational diabetes Individuals with other malignancies or with a history of other malignant tumors Individuals with a history of severe allergies, or who are allergic to any active or inactive ingredients of the study drug Pregnant or breastfeeding patients Researchers consider participants unsuitable for this clinical study due to any clinical or laboratory abnormalities or other reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JYP0035 monotherapy dose-escalation group<br>PART-1 Single Dose Escalation Group | Drug: JYP0035 Experimental Drug Treatment<br>* Single dose intervention<br>|
| Experimental: JYP0035 monotherapy dose-expansion group<br>PART-2 JYP0035 Monotherapy Dose Expansion Group | Drug: JYP0035 Experimental Drug Treatment<br>* Single dose intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the adverse event rate of this clinical trial | Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0. | From 8 weeks after the first administration up to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Area Under the Curve(AUC) | Area under the plasma concentration-time curve from zero to infinity | From 8 weeks after the first administration up to week 52 |