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

Guangzhou JOYO Pharma

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: JYP0035 Experimental Drug Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06158477

JYP0035M101

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

JYP0035 monotherapy dose-escalation group

Experimental group

Description:

PART-1 Single Dose Escalation Group

Treatment:

Drug: JYP0035 Experimental Drug Treatment

JYP0035 monotherapy dose-expansion group

Experimental group

Description:

PART-2 JYP0035 Monotherapy Dose Expansion Group

Treatment:

Drug: JYP0035 Experimental Drug Treatment