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

NCT07294508 | Recruiting Phase 2 DMC

• 1 other identifier: HLX87-BC001
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HER2 + Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)

  up to 26 months

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

  up to 37 months

Secondary Outcomes (5)

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

  up to 26 months

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

  up to 37 months

• Second progression-free survival (PFS2)

  up to 37 months

• Overall survival (OS)

  up to 37 months

• Incidence and severity of adverse events (AEs)

  up to 37 months

Study Arms (4)

HLX87+ HLX22

EXPERIMENTAL

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

HLX87+ Pertuzumab

EXPERIMENTAL

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

T-Dxd + Pertuzumab

ACTIVE COMPARATOR

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

THP

ACTIVE COMPARATOR

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

Interventions

HLX87 + HLX22 DRUG

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+ HLX22

HLX87 + Pertuzumab DRUG

HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan

HLX87+ Pertuzumab

T-Dxd + Pertuzumab DRUG

T-Dxd is a HER2-targeted ADC

T-Dxd + Pertuzumab

THP DRUG

Pertuzumab+ Trastuzumab+Docetaxel

THP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Advanced or metastatic breast cancer.
• HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
• 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).
• \. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.
• \. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.
• \. Life expectancy ≥ 12 weeks. 9. Adequate organ functions

You may not qualify if:

• \. 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).
• \. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.
• \. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.
• \. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness .
• \. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
• \. 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).
• \. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.
• \. 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.
• \. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei Ma, Dr

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maoqing Fu, Dr

CONTACT

021-33395800; Maoqing_fu@henlius.com

Ma

CONTACT

01067781331; Mafei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)