A Phase 2/3 interventional study of HLX87 + HLX22 and HLX87 + Pertuzumab in HER2 + Breast Cancer, sponsored by Shanghai Henlius Biotech. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Shanghai Henlius Biotech · Phase 2/3, Interventional, and Treatment
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
The study consists of two stages Stage I is an open-label, multicenter, randomized, parallel-controlled phase II clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on ORR and PFS results.
Stage II is an open-label, multicenter, randomized, parallel-controlled phase III clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on PFS results.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 706 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shanghai Henlius Biotech is the lead sponsor of 127 studies on the registry; 53 are open to participants now.
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1. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:
5. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.
7. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.
8. Life expectancy ≥ 12 weeks. 9. Adequate organ functions
Exclusion Criteria:
1. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).
3. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.
4. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.
6. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness .
7. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
9. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia).
10. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.
12. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs.
13. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.
Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first).
Drug: HLX87 + HLX22
atients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first).
Drug: HLX87 + Pertuzumab
Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first).
Drug: T-Dxd + Pertuzumab
Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first).
Drug: THP
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2 .
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan
T-Dxd is a HER2-targeted ADC
Pertuzumab+ Trastuzumab+Docetaxel
Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)
Time frame: up to 26 months
Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)
Time frame: up to 37 months
● ORR (assessed by the investigator as per RECIST v1.1)
Time frame: up to 26 months
● PFS (assessed by the investigator as per RECIST v1.1)
Time frame: up to 37 months
Second progression-free survival (PFS2)
Time frame: up to 37 months
Overall survival (OS)
Time frame: up to 37 months
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 6.0
Time frame: up to 37 months
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Shanghai Henlius Biotech