RecruitingPhase 2NCT06649331

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer:A Prospective, Open-label, Phase 2 Trial


Sponsor

Fudan University

Enrollment

160 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a platform study testing whether re-treating patients with a class of drugs called antibody-drug conjugates (ADCs) — targeted therapies that deliver chemotherapy directly to cancer cells — can still work in metastatic breast cancer patients who have already received an ADC but whose cancer has progressed. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic breast cancer that has come back - You have already received at least one ADC treatment - You have measurable disease on imaging - If your breast cancer is hormone receptor-positive, you have already received a CDK4/6 inhibitor - Your blood counts, liver, and kidney function are at acceptable levels **You may NOT be eligible if...** - You have not previously received an ADC - Your organ function is too poor for treatment - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSHR-A1811

A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.

DRUGSHR-A1921

A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.

DRUGSHR-A2009

A HER3-directed ADC, via intravenous (into the vein) infusion per protocol.

DRUGSHR-A2102

A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.

DRUGFamitinib

A VEGFR inhibitor administered orally per the protocol.

DIETARY_SUPPLEMENTFat Module Formula for Special Medical Purposes

This nutritional formulation is composed primarily of medium-chain triglycerides (MCT), which are metabolized by the liver to induce nutritional ketosis, thereby significantly elevating circulating levels of beta-hydroxybutyrate (BHB).

DRUGTrastuzumab (or biosimilar)

An anti-HER2 antibody, via intravenous (into the vein) infusion or subcutaneous per protocol.

DRUG9MW2821

A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.


Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06649331


Related Trials