A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

NCT07294508
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Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
706
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Lead sponsor
Shanghai Henlius Biotech
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Start date
2026-02-27
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Number of sites
1
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Summary
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
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Short title
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
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Official title
An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2030-12-30
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First posted
2025-12-19
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Registry last updated
2026-03-20
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Primary completion date
2028-01-15
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Start date
2026-02-27
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Participants
706
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Participant count basis
Estimated
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Planned participants
706
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Shanghai Henlius Biotech
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07294508
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ClinicalTrials.gov ID
NCT07294508
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)

    Timeframe: up to 26 months

  2. Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)

    Timeframe: up to 37 months

  1. ● ORR (assessed by the investigator as per RECIST v1.1)

    Timeframe: up to 26 months

  2. ● PFS (assessed by the investigator as per RECIST v1.1)

    Timeframe: up to 37 months

  3. Second progression-free survival (PFS2)

    Timeframe: up to 37 months

  4. Overall survival (OS)

    Timeframe: up to 37 months

  5. Incidence and severity of adverse events (AEs)

    Timeframe: up to 37 months

    severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 6.0

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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:

    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

  • 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.

Sources for eligibility
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  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)