Evaluating JYP0035 capsule for advanced solid tumors
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
Run by Guangzhou JOYO Pharma Co., Ltd · NCT06158477 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2027 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT06158477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with advanced solid tumors and an ECOG performance status of 0 or 1.
✕Probably not a fit
Patients who have not recovered from previous treatment-related adverse events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is not widely tested, similar studies evaluating new drug candidates in advanced solid tumors have shown promise.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Zhang Jian, MD
- Email: Syner2000@163.com
- Phone: 021-34778299
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MK-2010 with Sac-TMT in advanced solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.