Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525298
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Open Label Trial to Investigate the Safety Tolerability and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase PARP Inhibitor or Trastuzumab Deruxtecan T-DXd an Antibody Drug Conjugate ADC in Participants With Specified Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This trial investigates a new drug EIS-12656 in participants with specified advanced solid tumors carrying pre-specified mutations The trial consists of a dose escalation part Phase 1 and a dose expansion part Phase 2
Detailed Description:
The trial is a Phase 12 open label uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient HRD mutations
In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part
In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose RP2D Module 1 or EIS-12656 in combination with a PARPi or T-DXd Modules 2 and 3 The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination
In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part
In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose RP2D Module 1 or EIS-12656 in combination with a PARPi or T-DXd Modules 2 and 3 The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None