MedTrace Logo

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

NCT06649331 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SHR-A1811

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

DRUG

SHR-A1921

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

DRUG

SHR-A2009

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

DRUG

SHR-A2102

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

DRUG

Famitinib

A VEGFR inhibitor administered orally per the protocol.

DIETARY_SUPPLEMENT

Fat 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).

DRUG

Trastuzumab (or biosimilar)

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

DRUG

9MW2821

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, M.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649331 on ClinicalTrials.gov