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

NCT06158477 | Recruiting Phase 1 DMC

• 1 other identifier: JYP0035M101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess Area Under the Curve(AUC)

  From 8 weeks after the first administration up to week 52

Study Arms (2)

JYP0035 monotherapy dose-escalation group

EXPERIMENTAL

PART-1 Single Dose Escalation Group

Drug: JYP0035 Experimental Drug Treatment

JYP0035 monotherapy dose-expansion group

EXPERIMENTAL

PART-2 JYP0035 Monotherapy Dose Expansion Group

Drug: JYP0035 Experimental Drug Treatment

Interventions

JYP0035 Experimental Drug Treatment DRUG

Single dose intervention

JYP0035 monotherapy dose-escalation group; JYP0035 monotherapy dose-expansion group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chengdu JOYO pharma Co., Ltd.: lead
• Guangzhou JOYO Pharma Co., Ltd: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 311215, China

RECRUITING

Central Study Contacts

Zhang Jian, MD

CONTACT

021-34778299; Syner2000@163.com

Huang Hongming, MD

CONTACT

028-85420509; Honghm3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)