Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05955105
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
Sponsor:
Innolake Biopharm
Organization:
Study Overview
Official Title:
A Phase Ib/IIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
Status:
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:
This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.
Detailed Description:
This is a two-part study consists of dose escalation and expansion in selected indications. The dose escalation part adopts a 3+3 protocol design and consists of 2 cohorts. Based on the data obtained from the escalation study, selected dose cohort will be expanded in 10 tumor types to further investigate the efficacy of the combination therapy. Subjects will be assessed for safety and efficacy outcomes at pre-specified time points.
Study Oversight
Has Oversight DMC:
False
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?: