Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 311215, China
Location status: Recruiting
NCT Number: NCT06158477
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.
Interested in participating?
Request Info18 year–74 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 311215, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose intervention
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.
Time frame: From 8 weeks after the first administration up to week 52
Area under the plasma concentration-time curve from zero to infinity
Contact information is provided by the study sponsor or research team.
Chengdu JOYO pharma Co., Ltd.
Industry
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
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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