Clinical trial NCT06158477: A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Guangzhou JOYO Pharma Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou JOYO Pharma Co., Ltd
First posted: 2023-12-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Assess the adverse event rate of this clinical trial
timeFrame: From 8 weeks after the first administration up to week 52
Secondary outcomes:
measure: Assess Area Under the Curve(AUC)
timeFrame: From 8 weeks after the first administration up to week 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: