RecruitingPhase 1Phase 2NCT06298084

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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

152 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests HER3-DXd, a new antibody-drug treatment that targets a protein called HER3 on breast cancer cells, in patients with advanced breast cancer that has progressed while on or after treatment with a similar drug called T-DXd (trastuzumab deruxtecan). **You may be eligible if...** - You are 18 or older with confirmed advanced (metastatic or locally unresectable) breast cancer - You have been previously treated with T-DXd and your cancer progressed during or within 2 months of stopping that treatment - You have HER2-positive breast cancer and have also received trastuzumab and a taxane chemotherapy - OR you have HER2-low breast cancer and have received a taxane; if HR-positive, you also need prior endocrine therapy and CDK4/6 inhibitor treatment **You may NOT be eligible if...** - Your cancer has never been treated with T-DXd - You have not met the required prior therapy criteria specific to your cancer subtype - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPatritumab deruxtecan

5.6 mg/kg every 21 days

DRUGOlaparib

100 mg b.i.d PO days 8-14 every 21 days


Locations(1)

Gustave Roussy Institut

Villejuif, France

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NCT06298084


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