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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: JYP0035 Experimental Drug Treatment

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhang Jian, MD; Phone Number: 086 021-34778299; Email: Syner2000@163.com
• Study Contact Backup: Name: Huang Hongming, MD; Phone Number: 086 028-85420509; Email: Honghm3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JYP0035 monotherapy dose-escalation group; PART-1 Single Dose Escalation Group	Drug: JYP0035 Experimental Drug Treatment; Single dose intervention
Experimental: JYP0035 monotherapy dose-expansion group; PART-2 JYP0035 Monotherapy Dose Expansion Group	Drug: JYP0035 Experimental Drug Treatment; Single dose intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chengdu JOYO pharma Co., Ltd.
• Collaborators: Guangzhou JOYO Pharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: JYP0035M101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No