Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162221
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-11-30
Brief Title:
Study of RASON Inhibitor Combinations in Patients with Advanced RAS-mutated NSCLC
Sponsor:
Revolution Medicines Inc
Organization:
Revolution Medicines Inc
Study Overview
Official Title:
A Platform Study of RASON Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer NSCLC
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:
The purpose of this platform study is to evaluate the safety tolerability pharmacokinetics PK and preliminary antitumor activity of novel RASON inhibitors combined with Standards of Care SOC or with each other
The first two subprotocols include the following
Subprotocol A RMC-6291 SOC Subprotocol B RMC-6236 SOC
The first two subprotocols include the following
Subprotocol A RMC-6291 SOC Subprotocol B RMC-6236 SOC
Detailed Description:
The platform study design allows combinations of RASON inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on NSCLC
This is an open-label platform Phase 1b2 study to evaluate the safety tolerability pharmacokinetics PK and preliminary antitumor activity of novel RASON inhibitors combined with Standard of Care SOC and to define the Recommended Phase 2 Dose and Schedule RP2DS Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol
Subprotocol A is an open-label multicenter Phase 1b2 study of RMC-6291 in combination with pembrolizumab with or without chemotherapy in patients with KRAS G12C-mutated advanced solid tumors
Subprotocol B is an open-label multicenter Phase1b2 study of RMC-6236 in combination with pembrolizumab with or without chemotherapy in patients with RAS-mutated non-small cell lung cancer NSCLC
Each subprotocol consists of two parts Part 1 - Dose Exploration and Part 2 - Dose Expansion
This is an open-label platform Phase 1b2 study to evaluate the safety tolerability pharmacokinetics PK and preliminary antitumor activity of novel RASON inhibitors combined with Standard of Care SOC and to define the Recommended Phase 2 Dose and Schedule RP2DS Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol
Subprotocol A is an open-label multicenter Phase 1b2 study of RMC-6291 in combination with pembrolizumab with or without chemotherapy in patients with KRAS G12C-mutated advanced solid tumors
Subprotocol B is an open-label multicenter Phase1b2 study of RMC-6236 in combination with pembrolizumab with or without chemotherapy in patients with RAS-mutated non-small cell lung cancer NSCLC
Each subprotocol consists of two parts Part 1 - Dose Exploration and Part 2 - Dose Expansion
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