Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094777
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-10-16
Brief Title:
A Study of HY-0102 in Patients With Advanced Solid Tumors
Sponsor:
Shanghai YingLi Pharmaceutical Co Ltd
Organization:
Shanghai YingLi Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Multicenter Open-label Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of HY-0102 Monotherapy in Patients With Locally AdvancedMetastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This is a phase 1 open label multicenter study to evaluate the maximum tolerance safety tolerance and PK of HY-0102 administered intravenously IV once every two weeks in patients with advanced solid tumors so as to confirm the recommended phase 2 dose of HY-0102 and obtain the preliminary efficacy information of patients with advanced solid tumors
Detailed Description:
This is a Phase I trial to evaluate the safety tolerability pharmacokinetics and preliminary antitumor activity of HY-0102 administered intravenously IV once every two weeks in adult patients with locally advancedmetastatic malignant solid tumors urothelial carcinoma colorectal and pancreatic cancers etc
Three dosing cohorts are planned with the doses of 5 10 and 15 mgkg The study will apply a standard 33 dose escalation design in dose escalationDose expansion will enroll approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase
The number of enrolled patients is estimated to be up to 50 The dose limiting toxicity evaluation period will be the first 28 days Cycle 1 and subsequent cycles will be 4 weeks in duration Patients will receive the investigational drug on Day 1 of cycle 1 followed by 28 days of observation HY-0102 will be administered IV once every two weeks for Cycle 2 and beyond
Three dosing cohorts are planned with the doses of 5 10 and 15 mgkg The study will apply a standard 33 dose escalation design in dose escalationDose expansion will enroll approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase
The number of enrolled patients is estimated to be up to 50 The dose limiting toxicity evaluation period will be the first 28 days Cycle 1 and subsequent cycles will be 4 weeks in duration Patients will receive the investigational drug on Day 1 of cycle 1 followed by 28 days of observation HY-0102 will be administered IV once every two weeks for Cycle 2 and beyond
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