A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158477
• Other study ID #: JYP0035M101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 15, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: November 2023
• Source: Guangzhou JOYO Pharma Co., Ltd
• Contact: Zhang Jian, MD
• Phone: 021-34778299
• Email: Syner2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• JYP0035 Experimental Drug Treatment
Single dose intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu JOYO pharma Co., Ltd.	Guangzhou JOYO Pharma Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the adverse event rate of this clinical trial	Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0.	From 8 weeks after the first administration up to week 52
Secondary	Assess Area Under the Curve(AUC)	Area under the plasma concentration-time curve from zero to infinity	From 8 weeks after the first administration up to week 52