A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients

NCT ID: NCT06832202

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2029-12-01

Brief Summary

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).

Detailed Description

experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).

Conditions

HER2-low Hormone Receptor Positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), Q3W

Group Type: EXPERIMENTAL

HLX22

Intervention Type: DRUG

HLX22 15mg/kg Q3W

Trastuzumab Deruxtecan

Intervention Type: DRUG

Trastuzumab Deruxtecan 5.4mg/kg Q3W

Interventions

HLX22

HLX22 15mg/kg Q3W

Intervention Type: DRUG

Trastuzumab Deruxtecan

Trastuzumab Deruxtecan 5.4mg/kg Q3W

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yun Li

Role: CONTACT

Shirley_Li@henlius.com

+86-15800864157

Other Identifiers

HLX22-BC201

Identifier Type: -

Identifier Source: org_study_id