Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298084
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-02-12
Brief Title:
Dose-Expansion Modular Study To Explore the Safety Tolerability and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer ABC After Progression on T-DXd
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase 1b2 Multicenter Open-label Dose-Expansion Modular Study To Explore the Safety Tolerability and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer ABC After Progression on T-DXd
Status:
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:
ICARUSBREAST02
Brief Summary:
ICARUS-BREAST02 is an open-label multicenter phase 1b2 platform study that aims to evaluate the safety tolerability and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC
The first 2 modules will evaluate i safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd Module 1 and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd Module 0
The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose RP2D of the combination containing HER3-DXd
The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate ORR at 6 months
The first 2 modules will evaluate i safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd Module 1 and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd Module 0
The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose RP2D of the combination containing HER3-DXd
The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate ORR at 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 20233668 | OTHER | CSET number | None |