Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774952
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2021-02-25
Brief Title:
Dose Escalation of RMC-5552 Monotherapy in RelapsedRefractory Solid Tumors
Sponsor:
Revolution Medicines Inc
Organization:
Revolution Medicines Inc
Study Overview
Official Title:
A Phase 11b Open-Label Multicenter Dose-Escalation Study of RMC 5552 Monotherapy in Adult Subjects With RelapsedRefractory Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 evaluate the safety tolerability pharmacokinetic PK and pharmacodynamic PD profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsedrefractory solid tumors and to identify the recommended Phase 2 dose RP2D
Detailed Description:
This is an open-label multicenter Phase 11b study of RMC-5552 monotherapy in participants with advanced relapsed or refractory solid tumors The study will include 2 components 1 a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2 a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutationsrearrangements that result in hyperactivation of the mTOR pathway Participants will be treated until disease progression per RECIST v11 unacceptable toxicity or other criteria for withdrawal are met whichever occurs first
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