Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787042
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-02
First Post:
2021-02-16
Brief Title:
Phase 1a and Phase 2 Study for Safety Preliminary Efficacy PK and PD of ST-067
Sponsor:
Simcha IL-18 Inc
Organization:
Simcha IL-18 Inc
Study Overview
Official Title:
A First-In-Human Phase 12 Open-Label Study of Intravenous ST-067 Subcutaneous ST-067 With or Without Obinutuzumab Pre-Treatment and ST-067 in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 multiphase multicenter study which includes a Phase 1a open-label dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab Gazyva pre-treatment by IV infusion and in combination with pembrolizumab A Phase 2 monotherapy arm is also planned the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial
Detailed Description:
Phase 1a is designed to determine the maximum tolerated dose MTD and recommended Phase 2 dose RP2D of ST067 administered by subcutaneous SC or intravenous IV dosing in subjects with relapsed or refractory solid tumors as well as to determine the MTD and recommended Phase 2 dose of ST067 administered SC with obinutuzumab Gazyva as pretreatment in subjects with relapsed or refractory solid tumors using a modified toxicity probability interval mTPI design There will be evaluations of ST-067 PK and PD effects
Phase 2 will evaluate the preliminary efficacy of ST-067 administered at the RP2D to patients with the following tumor types A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts RECIST 11 will be used to assess tumor response every 8-12 weeks
Melanoma n28
Renal cell carcinoma n25
Triple-negative best cancer n25
Non-small cell lung cancer n25
squamous cell carcinoma of the head and neck n28
MSI-Hi tumors n25
A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts RECIST 11 will be used to assess tumor response every 8-12 weeks
Safety will be assessed for each patient throughout the study
Phase 2 will evaluate the preliminary efficacy of ST-067 administered at the RP2D to patients with the following tumor types A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts RECIST 11 will be used to assess tumor response every 8-12 weeks
Melanoma n28
Renal cell carcinoma n25
Triple-negative best cancer n25
Non-small cell lung cancer n25
squamous cell carcinoma of the head and neck n28
MSI-Hi tumors n25
A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts RECIST 11 will be used to assess tumor response every 8-12 weeks
Safety will be assessed for each patient throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KEYNOTE-E64 | OTHER | Merck | None |