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A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients

13. september 2026 opdateret af: Shanghai Henlius Biotech

A Multicenter, Randomized, Double-Blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC

This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
  • Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
  • HER2 positive confirmed by central laboratory.
  • Hormone receptor (HR) status confirmed by local laboratory.
  • Patients who have progressed after treatment containing within HER2 ADC
  • Presence of at least one measurable lesion according to the RECIST v1.1.
  • Adequate organ function

Exclusion Criteria:

  • History of any other malignancy within 2 years prior to signing the ICF.
  • Prior use of doxorubicin with a cumulative in vivo dose of > 360 mg/m2.
  • Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.0.
  • Uncontrolled or severe cardiovascular disease.
  • History of cerebrovascular accident within 6 months prior to randomization.
  • Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment.
  • Active infection.
  • Active tuberculosis.
  • Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
  • Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization
  • Pregnant or lactating women or women who plan to become pregnant during the study period.
  • History of immunodeficiency or history of organ transplantation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
HLX22 + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)
Medicin: HLX22
15 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W
Medicin: Trastuzumab
Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
Medicin: Capecitabine
1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
Medicin: Paclitaxel
175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
Medicin: Docetaxel
75-100 mg/m2, D1, Q3W, IV
Medicin: Eribulin
1.4 mg/m2, D1 and D8, Q3W, IV
Medicin: Vinorelbine
25-30 mg/m2, D1 and D8, Q3W, IV
Placebo komparator: Control group
placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)
Medicin: Trastuzumab
Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
Medicin: Capecitabine
1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
Medicin: Paclitaxel
175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
Medicin: Docetaxel
75-100 mg/m2, D1, Q3W, IV
Medicin: Eribulin
1.4 mg/m2, D1 and D8, Q3W, IV
Medicin: Vinorelbine
25-30 mg/m2, D1 and D8, Q3W, IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate (ORR) assessed by the blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Tidsramme: Up to 2 years
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1
Up to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS) assessed by the BICR as per RECIST 1.1
Tidsramme: up to 5 years
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
up to 5 years
ORR assessed by the investigator as per RECIST 1.1
Tidsramme: up to 2 years
up to 2 years
PFS assessed by the investigator as per RECIST 1.1
Tidsramme: up to 5 years
up to 5 years
Duration of response (DoR) assessed by the BICR and the investigator as per RECIST 1.1
Tidsramme: up to 2 years
DoR is defined as the time from the date of first achievement of CR or PR (whichever is documented first) to the date of the first documentation of PD or death (whichever occurs first)
up to 2 years
Overall survival (OS)
Tidsramme: up to 5 years
OS is defined as the time from randomization to death due to any cause.
up to 5 years
Adverse Events (AEs)
Tidsramme: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 5 years
Incidence and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
time from the date of the first dose of study drug until 90 days after last dose, assessed up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Henlius Biotech

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. oktober 2026

Primær færdiggørelse (Anslået)

31. marts 2028

Studieafslutning (Anslået)

4. december 2029

Datoer for studieregistrering

Først indsendt

13. september 2026

Først indsendt, der opfyldte QC-kriterier

13. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HLX22-BC202

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