Evaluating JYP0035 capsule for 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

This study is testing a new capsule called JYP0035 to see if it's safe and how it works in people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Guangzhou JOYO Pharma Co., Ltd (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06158477 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial aims to assess the safety, tolerability, and pharmacokinetics of the JYP0035 capsule in patients with advanced solid tumors. Participants will receive escalating doses of the drug during the dose-escalation phase, followed by a continuation at the identified dose in the dose-expansion phase. The study is single-arm, meaning there is no comparison group, and focuses on understanding how the drug behaves in the body and its safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors and an ECOG performance status of 0 or 1.

Not a fit: Patients who have not recovered from previous treatment-related adverse events may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors.

How similar studies have performed: While this approach is not widely tested, similar studies evaluating new drug candidates in advanced solid tumors have shown promise.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zhang Jian, MD

Conditions: Advanced Solid Tumors