Advanced Solid Tumors
Conditions
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.
Interventions
DRUGJYP0035 Experimental Drug Treatment
Single dose intervention
Sponsors
Guangzhou JOYO Pharma Co., Ltd
Chengdu JOYO pharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the adverse event rate of this clinical trial | From 8 weeks after the first administration up to week 52 | Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Area Under the Curve(AUC) | From 8 weeks after the first administration up to week 52 | Area under the plasma concentration-time curve from zero to infinity |
Countries
China
Contacts
Primary ContactZhang Jian, MD
Backup ContactHuang Hongming, MD
Outcome results
None listed