Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426680
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-19
Brief Title:
A Study of the ILB-3101 in Patients With Advanced Solid Tumors
Sponsor:
Innolake Biopharm
Organization:
Innolake Biopharm
Study Overview
Official Title:
Phase III Study of the ILB-3101 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ILB-3101 is a fully humanized IgG1 antibody-drug conjugate ADC which specifically binds to B7-H3 a target wildly expressed on solid tumor cells The objectives of this study are to investigate the safety tolerability pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients
Detailed Description:
This is an open-label multi-center dose-escalation and expansion first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors This study will consist of two parts A Part Ia dose escalation stage and a Part Ib dose expansion stage
The objectives of this study are to evaluate the safety tolerability PK and preliminary anti-tumor activity describe the dose-limiting toxicities DLTs and determine the maximum tolerated dose MTD or maximum administered dose MAD of HS-20093
Part I Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies or no standard or available curative therapy exists The dose escalation will include an initial accelerated titration design followed by 33 design
Part II Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase I The dose expansion study will be conducted in populations with the following indications ovarian cancer small cell lung cancer head and neck squamous cell carcinoma soft tissue sarcoma including uterine sarcoma triple negative breast cancer esophageal squamous cell carcinoma prostate cancer etc
All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists
The objectives of this study are to evaluate the safety tolerability PK and preliminary anti-tumor activity describe the dose-limiting toxicities DLTs and determine the maximum tolerated dose MTD or maximum administered dose MAD of HS-20093
Part I Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies or no standard or available curative therapy exists The dose escalation will include an initial accelerated titration design followed by 33 design
Part II Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase I The dose expansion study will be conducted in populations with the following indications ovarian cancer small cell lung cancer head and neck squamous cell carcinoma soft tissue sarcoma including uterine sarcoma triple negative breast cancer esophageal squamous cell carcinoma prostate cancer etc
All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists
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