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

NCT06832202 | Recruiting Phase 2 DMC

• 1 other identifier: HLX22-BC201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

HER2-low Hormone Receptor Positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  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.

  Up to 5 years

• Objective response rate (ORR)

  Objective Response Rate (ORR) assessed by IRRC per RECIST v1.1. ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1

  Up to 2 years

Secondary Outcomes (3)

• PFS

  Up to 5 years

• ORR

  Up to 2 years

• Aderse events (AE)

  Up to 5 years

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Drug: HLX22; Drug: Trastuzumab Deruxtecan

Interventions

HLX22 DRUG

HLX22 15mg/kg Q3W

Experimental group

Trastuzumab Deruxtecan DRUG

Trastuzumab Deruxtecan 5.4mg/kg Q3W

Experimental group

Eligibility Criteria

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

You may qualify if:

• Male/female who are at least 18 years of age on the day of signing the informed consent.
• With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
• 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
• Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
• ECOG PS: 0-1.
• Expected survival ≥ 6 months.
• Had adequate organ function

You may not qualify if:

• Patients with other malignant tumors within 3 years before the randomization
• Previous treatment with any HER2-target therapy
• Uncontrolled or significant cardiovascular disease or infection
• Lung-specific intercurrent clinically significant illnesses
• Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
• Patients with spinal cord compression or clinically active central nervous system metastases

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Interventions

trastuzumab deruxtecan

Central Study Contacts

Yun Li

CONTACT

+86-15800864157; Shirley_Li@henlius.com

Study Design

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

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-01

Locations

CN (1)