Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05279859
Status:
WITHDRAWN
Last Update Posted:
2022-06-15
First Post:
2022-03-05
Brief Title:
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
Sponsor:
Erasca Inc
Organization:
Erasca Inc
Study Overview
Official Title:
A Phase 1b2 Master Protocol of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Hematologic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERKULES-4
Brief Summary:
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies
To determine the Maximum Tolerated Dose MTD andor Recommended Dose RD of ERAS-007 or ERAS-601 administered in combination with other cancer therapies
To evaluate the preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies
To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination
To determine the Maximum Tolerated Dose MTD andor Recommended Dose RD of ERAS-007 or ERAS-601 administered in combination with other cancer therapies
To evaluate the preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies
To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination
Detailed Description:
This is a Phase 1b2 open-label multicenter master protocol evaluating safety tolerability and preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies The study will commence with dose escalation cohorts ERAS-007 plus gilteritinib and ERAS-601 plus gilteritinib in study participants with relapsed or refractory RR Feline McDonough sarcoma FMS-like tyrosine kinase 3 FLT3 mutated acute myeloid leukemia AML Dose expansion will follow and will evaluate ERAS-007 or ERAS-601 drug combinations administered at the RD identified from each respective dose escalation cohort in study participants with RR FLT-3 mutated AML
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