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

Chengdu JOYO pharma Co., Ltd.1 site in 1 country75 target enrollmentJanuary 1, 2024

ConditionsAdvanced Solid Tumors

InterventionsJYP0035 Experimental Drug Treatment

Overview

Phase: Phase 1
Intervention: JYP0035 Experimental Drug Treatment
Conditions: Advanced Solid Tumors
Sponsor: Chengdu JOYO pharma Co., Ltd.
Enrollment: 75
Locations: 1
Primary Endpoint: Assess the adverse event rate of this clinical trial
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

December 1, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Chengdu JOYO pharma Co., Ltd.

Responsible Party

Sponsor

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