Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158477
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-28
Brief Title:
A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
Sponsor:
Chengdu JOYO pharma Co Ltd
Organization:
Guangzhou JOYO Pharma Co Ltd
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None