Actively Recruiting
A Clinical Trial Evaluating 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
204 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
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.
CONDITIONS
Official 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
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to study drug administration
- Participants agree to use reliable contraception methods from signing the informed consent form until 6 months after the last dose of the study drug
You will not qualify if you...
- Participants have not recovered to normal or 4 Grade 1 from any adverse events or complications caused by previous treatments before the first administration, excluding hair loss and pigmentation
- Patients with tumor invasion into major blood vessels shown by CT or MRI
- Patients with clinically significant cardiovascular or cerebrovascular diseases within 6 months before study drug administration, including atrial fibrillation and arrhythmias requiring treatment
- History of type 1 diabetes, type 2 diabetes, or gestational diabetes
- Individuals with other malignancies or history of other malignant tumors
- History of severe allergies or allergy to any ingredients of the study drug
- Pregnant or breastfeeding patients
- Researchers consider participants unsuitable due to clinical or laboratory abnormalities or other reasons
AI-Screening
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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
CONTACT
H
Huang Hongming, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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