Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05039177
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2021-09-01
Brief Title:
A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies
Sponsor:
Erasca Inc
Organization:
Erasca Inc
Study Overview
Official Title:
A Phase 1b2 Study of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Gastrointestinal Malignancies HERKULES-3
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
HERKULES-3
Brief Summary:
To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced GI malignancies
To determine the Maximum Tolerated Dose MTD andor Recommended Dose RD of ERAS-007 administered in combination with other cancer therapies
To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies
To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination
To determine the Maximum Tolerated Dose MTD andor Recommended Dose RD of ERAS-007 administered in combination with other cancer therapies
To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies
To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination
Detailed Description:
This is a Phase 1b2 open-label multicenter clinical study evaluating ERAS-007 in combination with other cancer therapies in study participants with GI malignancies This study will serve as a platform study allowing for evaluation of safetytolerability and efficacy of ERAS-007 in combination with other cancer therapies The study will initially commence with dose escalation of ERAS-007 administered in combination with encorafenib and cetuximab in study participants with metastatic colorectal cancer CRC harboring B-Raf proto-oncogene serinethreonine kinase BRAF V600E mutation and dose escalation of ERAS-007 administered in combination with palbociclib in study participants with metastatic CRC harboring Kirsten rat sarcoma KRAS or neuroblastoma rat sarcoma NRAS mutations and metastatic pancreatic adenocarcinoma with PDAC KRAS mutation Dose expansion will follow and will test ERAS-007 administered at the RD identified from each dose escalation arm in study participants with metastatic CRC
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