Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05768139
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-03-01
Brief Title:
First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Sponsor:
Scorpion Therapeutics Inc
Organization:
Scorpion Therapeutics Inc
Study Overview
Official Title:
First-in-Human Study of STX-478 a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Study STX-478-101 is a multipart open-label phase 12 study evaluating the safety tolerability pharmacokinetics PK and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with P13Ka mutations
Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive HR breast cancer Part 3 will evaluate STX-478 as combination therapy with fulvestrant and a CDK46 Inhibitor either Ribociclib or Palbociclib in participants with HR breast cancer
Each study part will include a 28-day screening period followed by treatment with STX-478 monotherapy or combination therapy
Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive HR breast cancer Part 3 will evaluate STX-478 as combination therapy with fulvestrant and a CDK46 Inhibitor either Ribociclib or Palbociclib in participants with HR breast cancer
Each study part will include a 28-day screening period followed by treatment with STX-478 monotherapy or combination therapy
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-000442-41 | EUDRACT_NUMBER | None | None |
| 2023-504807-94-00 | OTHER | EU CT Number | None |