Clinical trial · Interventional
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-low Hormone Receptor Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX22 | Drug | — | UNRESOLVED |
| Trastuzumab Deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), Q3W
- interventionNames
- Drug: HLX22
- Drug: Trastuzumab Deruxtecan
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 5 years
- description
- Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1 . PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male/female who are at least 18 years of age on the day of signing the informed consent. 2. With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer. 3. HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting 4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only. 5. ECOG PS: 0-1. 6. Expected survival ≥ 6 months. 7. Had adequate organ function Exclusion Criteria: 1. Patients with other malignant tumors within 3 years before the randomization 2. Previous treatment with any HER2-target therapy 3. Uncontrolled or significant cardiovascular disease or infection 4. Lung-specific intercurrent clinically significant illnesses 5. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis 6. Patients with spinal cord compression or clinically active central nervous system metastases
References
Publications (0)
Data not yet available