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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 706
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)
Study Overview
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Have a full understanding of the study content, and sign the informed consent form (ICF);
- •Aged ≥ 18 years at the time of signing the ICF, male or female;
- •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
- •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.
- •7. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-
- •8. Life expectancy ≥ 12 weeks.
- •Adequate organ functions
Exclusion Criteria
- •1. History of a second malignancy within 3 years prior to signing the ICF.
- •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
- •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 .
- •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.
- •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.
- •Pregnant or lactating women.
Arms & Interventions
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).
Intervention: HLX87 + HLX22 (Drug)
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).
Intervention: HLX87 + Pertuzumab (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).
Intervention: T-Dxd + Pertuzumab (Drug)
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).
Intervention: THP (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- ● 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)