Trials / Recruiting
RecruitingNCT06298084
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
Phase 1b/2, 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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, 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.
Conditions
- Breast Cancer Metastatic
- HER2-positive Metastatic Breast Cancer
- HER2 Low Breast Carcinoma
- Advanced Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Patritumab deruxtecan | 5.6 mg/kg every 21 days |
| DRUG | Olaparib | 100 mg b.i.d PO days 8-14 every 21 days |
Timeline
- Start date
- 2024-03-21
- Primary completion
- 2027-09-01
- Completion
- 2029-06-01
- First posted
- 2024-03-07
- Last updated
- 2024-03-29
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06298084. Inclusion in this directory is not an endorsement.