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

Sponsor
Fudan University
Study ID
NCT06649331
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
  • SHR-A1921 — DRUG
    A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
  • SHR-A2009 — DRUG
    A HER3-directed ADC, via intravenous (into the vein) infusion per protocol.
  • SHR-A2102 — DRUG
    A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
  • Famitinib — DRUG
    A VEGFR inhibitor administered orally per the protocol.
  • Fat Module Formula for Special Medical Purposes — DIETARY_SUPPLEMENT
    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).
  • Trastuzumab (or biosimilar) — DRUG
    An anti-HER2 antibody, via intravenous (into the vein) infusion or subcutaneous per protocol.
  • 9MW2821 — DRUG
    A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.

Study Details

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.

Key Dates

First listed
Oct 18, 2024
Start date
Oct 21, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    SHR-A1811 (HER2 ADC)
  • Experimental: B
    SHR-A1921 (TROP2 ADC)
  • Experimental: C
    SHR-A2009 (HER3 ADC)
  • Experimental: D
    SHR-A2102 (Nectin4 ADC)
  • Experimental: E
    SHR-A1811 (HER2 ADC) and Famitinib (VEGFR inhibitor)
  • Experimental: F
    SHR-A1811 (HER2 ADC) and Fat Module Formula for Special Medical Purposes (for Medium-Chain Triglyceride Supplementation)
  • Experimental: G
    9MW2821 (Nectin4 ADC)
  • Experimental: H
    9MW2821 (Nectin4 ADC) + trastuzumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: The observation period related to this endpoint is up to 36 months. ]

Central Contacts

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