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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

NCT06895031

Solid Tumor Pancreatic Ductal Adenocarcinoma (PDAC) Non-small Cell Lung Cancer (NSCLC) +1 more

RECRUITING PHASE1/PHASE2

Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

NCT06128148

Protein Kinase Inhibitors Other Protocol Specified Criteria Lung Neoplasms +1 more

RECRUITING PHASE1

JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

NCT06386146

Solid Tumors

RECRUITING PHASE1/PHASE2

A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.

NCT06487455

Advanced Solid Tumor

RECRUITING PHASE1

Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors

NCT06571422

Advanced Malignant Solid Tumors

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

JYP0035 monotherapy dose-escalation group

PART-1 Single Dose Escalation Group

Group Type EXPERIMENTAL

JYP0035 Experimental Drug Treatment

Intervention Type DRUG

Single dose intervention

JYP0035 monotherapy dose-expansion group

PART-2 JYP0035 Monotherapy Dose Expansion Group

Group Type EXPERIMENTAL

JYP0035 Experimental Drug Treatment

Intervention Type DRUG

Single dose intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JYP0035 Experimental Drug Treatment

Single dose intervention

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No