Actively Recruiting
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
Led by Chengdu JOYO pharma Co., Ltd. · Updated on 2024-11-18
75
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Chengdu JOYO pharma Co., Ltd.
Lead Sponsor
G
Guangzhou JOYO Pharma Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes the JYP0035 capsule in patients with advanced solid tumors. This Phase I clinical trial focuses on understanding the safety profile and pharmacokinetics of JYP0035 in this group. The trial addresses important questions about the drug's effects and behavior in the body for patients with serious cancers. Participants will receive JYP0035 capsules in two parts: first, an escalating dose phase (PART-1) to find the right dose, followed by a dose-expansion phase (PART-2) where the selected dose is given as monotherapy. This study has a single group design, meaning all participants receive the JYP0035 capsule without comparison to another treatment or placebo. During the trial, participants will be monitored for side effects and how much drug exposure they have from 8 weeks after the first dose up to 52 weeks. Researchers will assess adverse events and measure drug levels in the body over this time. The study lasts up to about one year, with regular safety checks and evaluations to understand the treatment’s effects and tolerability.
CONDITIONS
Brief Title
A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Participants have not recovered to normal or 4 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From administration up to 52 weeks
Participants receive a single dose of the experimental drug JYP0035 and are monitored for safety and tolerability.
Regular visits for safety and pharmacokinetic assessments from 8 weeks after the first administration up to week 52
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 311215
Actively Recruiting
Research Team
Z
Zhang Jian, MD
H
Huang Hongming, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here