A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: JYP0035 Experimental Drug Treatment
- Registration Number
- NCT06158477
- Lead Sponsor
- Chengdu JOYO pharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JYP0035 monotherapy dose-escalation group JYP0035 Experimental Drug Treatment PART-1 Single Dose Escalation Group JYP0035 monotherapy dose-expansion group JYP0035 Experimental Drug Treatment PART-2 JYP0035 Monotherapy Dose Expansion Group
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China