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NCT Number: NCT06158477

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

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 311215, China

Location status: Recruiting

Location contact

Zhang jian, M.D.

CONTACT

[email protected]

+86 021-34778299

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JYP0035 Experimental Drug Treatment

Drug

Single dose intervention

Primary outcomes

  1. Assess the adverse event rate of this clinical trial

    Time frame: From 8 weeks after the first administration up to week 52

    Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0.

Secondary outcomes

  1. Assess Area Under the Curve(AUC)

    Time frame: From 8 weeks after the first administration up to week 52

    Area under the plasma concentration-time curve from zero to infinity

Study contacts

Contact information is provided by the study sponsor or research team.

Huang Hongming, MD

CONTACT

[email protected]

028-85420509 ext. 086

Zhang Jian, MD

CONTACT

[email protected]

021-34778299 ext. 086

Sponsors and collaborators

Lead sponsor

Chengdu JOYO pharma Co., Ltd.

Industry

Collaborators

  • Guangzhou JOYO Pharma Co., Ltd

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 6, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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