Status:
RECRUITING
A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
Lead Sponsor:
Chengdu JOYO pharma Co., Ltd.
Collaborating Sponsors:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06158477
Start Date
January 1 2024
End Date
December 1 2027
Last Update
November 18 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 311215