A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT06158477
- Run by
- Chengdu JOYO pharma Co., Ltd.
- People needed
- 75
- Starts
- 2024-01-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2024-11-18
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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