Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463340
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-24
Brief Title:
Study of SGR-3515 In Participants With Advanced Solid Tumors
Sponsor:
Schrödinger Inc
Organization:
Schrödinger Inc
Study Overview
Official Title:
A First-In-Human Phase 1 Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to learn about the effects of a new study drug called SGR-3515 that may be a treatment for advanced solid tumors
Detailed Description:
SGR-3515-101 is a phase 1 fist-in-human single agent dose-escalation study designed to evaluate the safety tolerability dose limiting toxicities pharmacokinetics pharmacodynamics and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose recommended phase 2 dose and schedule of SGR-3515 in participants with advanced solid tumors hypothesized to be sensitive to Wee1Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway including but not limited to CCNE1 amplification
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