Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445062
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-20
Brief Title:
Study of RASON Inhibitors in Patients with Gastrointestinal Solid Tumors
Sponsor:
Revolution Medicines Inc
Organization:
Revolution Medicines Inc
Study Overview
Official Title:
A Platform Study of RASON Inhibitors in Patients with Gastrointestinal Solid Tumors
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 novel agents
The first three subprotocols include the following
Subprotocol A RMC-6236 5-fluorouracil-based regimens
Subprotocol B RMC-6236 cetuximab with or without mFOLFOX6
Subprotocol C RMC-6236 gemcitabine nab-paclitaxel
The first three subprotocols include the following
Subprotocol A RMC-6236 5-fluorouracil-based regimens
Subprotocol B RMC-6236 cetuximab with or without mFOLFOX6
Subprotocol C RMC-6236 gemcitabine nab-paclitaxel
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 GI cancers
This is an open-label platform study to evaluate the safety tolerability pharmacokinetics PK and preliminary antitumor activity of novel RASON inhibitors combined with Standard of Care SOC or with novel agents and to define the Recommended Phase 2 Dose and Schedule RP2DS Enrollment of patients with RAS mutations will be specified in each subprotocol
Subprotocol A is an open-label multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with treatment-naïve unresectable or metastatic colorectal cancer or treatment-naïve metastatic pancreatic ductal adenocarcinoma Subprotocol B is an open-label multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or patients with previously treated or treatment-naïve metastatic pancreatic ductal adenocarcinoma Subprotocol C is an open-label multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma Each subprotocol consists of two parts Part 1 - Dose Exploration and Part 2 - Dose Expansion
This is an open-label platform study to evaluate the safety tolerability pharmacokinetics PK and preliminary antitumor activity of novel RASON inhibitors combined with Standard of Care SOC or with novel agents and to define the Recommended Phase 2 Dose and Schedule RP2DS Enrollment of patients with RAS mutations will be specified in each subprotocol
Subprotocol A is an open-label multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with treatment-naïve unresectable or metastatic colorectal cancer or treatment-naïve metastatic pancreatic ductal adenocarcinoma Subprotocol B is an open-label multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or patients with previously treated or treatment-naïve metastatic pancreatic ductal adenocarcinoma Subprotocol C is an open-label multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma 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