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 oppdatert av: 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from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mingxia Xu
- Telefonnummer: +86 18905266695
- E-post: Mingxia_Xu@henlius.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental group
HLX22 + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)
|
15 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W
Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
75-100 mg/m2, D1, Q3W, IV
1.4 mg/m2, D1 and D8, Q3W, IV
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)
|
Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
75-100 mg/m2, D1, Q3W, IV
1.4 mg/m2, D1 and D8, Q3W, IV
25-30 mg/m2, D1 and D8, Q3W, IV
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
31. oktober 2026
Primær fullføring (Antatt)
31. mars 2028
Studiet fullført (Antatt)
4. desember 2029
Datoer for studieregistrering
Først innsendt
13. september 2026
Først innsendt som oppfylte QC-kriteriene
13. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Hudsykdommer
- Bryst sykdommer
- Hud- og bindevevssykdommer
- Brystneoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Nukleinsyrer, nukleotider og nukleosider
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Alkaloider
- Indoler
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Taxoider
- Cyclodecanes
- Diterpenes
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Vinca -alkaloider
- Secologanin tryptaminalkaloider
- Indolalkaloider
- Indolizidiner
- Indolisiner
- Deoxyribonucleosides
- Fluorouracil
- Docetaxel
- Trastuzumab
- Capecitabin
- Vinorelbin
- Paclitaxel
- eribulin
Andre studie-ID-numre
- HLX22-BC202
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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