A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
NCT ID: NCT07294508
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
706 participants
INTERVENTIONAL
2026-01-25
2030-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HLX87+ HLX22
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).
HLX87 + HLX22
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+ Pertuzumab
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).
HLX87 + Pertuzumab
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan
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).
T-Dxd + Pertuzumab
T-Dxd is a HER2-targeted ADC
THP
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).
THP
Pertuzumab+ Trastuzumab+Docetaxel
Interventions
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HLX87 + HLX22
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 + Pertuzumab
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan
T-Dxd + Pertuzumab
T-Dxd is a HER2-targeted ADC
THP
Pertuzumab+ Trastuzumab+Docetaxel
Eligibility Criteria
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Inclusion Criteria
1. Advanced or metastatic breast cancer.
2. HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
3. Positive or negative for hormone receptor HR (including estrogen receptor \[ER\] and progesterone receptor \[PgR\]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Fei Ma, Dr
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Central Contacts
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Other Identifiers
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HLX87-BC001
Identifier Type: -
Identifier Source: org_study_id