Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130254
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-11-08
Brief Title:
Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib MRTX849 in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors With a Focus on Gynecological Breast Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib MRTX849 in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors With a Focus on Gynecological Breast Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate safety and tolerability while establishing the recommended dose of the investigational drug combination of adagrasib and olaparib that can be given to participants with advanced solid tumors with a KRAS G12C andor KEAP1 mutation
Detailed Description:
Primary Objectives
To evaluate the safety and tolerability of adagrasib in combination with olaparib in participants with KRAS G12C mutant advanced solid tumors
To establish the maximum tolerated dose andor recommended phase 2 dose MTDRP2D of the combination in participants with KRAS G12C mutant advanced solid tumors
Secondary Objectives
To assess the preliminary antitumor activity of the combination of adagrasib in combination with olaparib using objective response rate ORR RECISTv11 complete response plus partial response CRPR
Exploratory Objectives
To assess predictive biomarkers of response and resistance to the combination of adagrasib with olaparib
To evaluate the pharmacodynamic profile of the combination of adagrasib and olaparib in participants with KRAS G12C mutant advanced solid tumors
To assess potential mechanisms of response and resistance by comparing serially collected circulating tumor DNA ctDNA samples and biopsies in responders and non-responders
To evaluate the safety and tolerability of adagrasib in combination with olaparib in participants with KRAS G12C mutant advanced solid tumors
To establish the maximum tolerated dose andor recommended phase 2 dose MTDRP2D of the combination in participants with KRAS G12C mutant advanced solid tumors
Secondary Objectives
To assess the preliminary antitumor activity of the combination of adagrasib in combination with olaparib using objective response rate ORR RECISTv11 complete response plus partial response CRPR
Exploratory Objectives
To assess predictive biomarkers of response and resistance to the combination of adagrasib with olaparib
To evaluate the pharmacodynamic profile of the combination of adagrasib and olaparib in participants with KRAS G12C mutant advanced solid tumors
To assess potential mechanisms of response and resistance by comparing serially collected circulating tumor DNA ctDNA samples and biopsies in responders and non-responders
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 |
|---|---|---|---|
| NCI-2023-09685 | OTHER | NCI-CTRP Clinical Registry | None |