Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JYP0035 Experimental Drug Treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JYP0035 monotherapy dose-escalation group
- description
- PART-1 Single Dose Escalation Group
- interventionNames
- Drug: JYP0035 Experimental Drug Treatment
- type
- EXPERIMENTAL
- label
- JYP0035 monotherapy dose-expansion group
- description
- PART-2 JYP0035 Monotherapy Dose Expansion Group
- interventionNames
- Drug: JYP0035 Experimental Drug Treatment
Primary outcomes (1)
- measure
- Assess the adverse event rate of this clinical trial
- timeFrame
- From 8 weeks after the first administration up to week 52
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available