NCT06832202 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Henlius Biotech |
| Condition | HER2-low Hormone Receptor Positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-04-16 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06832202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2-low Hormone Receptor Positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06832202 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06832202 currently recruiting?
Yes, NCT06832202 is actively recruiting participants. Contact the research team at Shirley_Li@henlius.com for enrollment information.
Where is the NCT06832202 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06832202 clinical trial?
NCT06832202 is sponsored by Shanghai Henlius Biotech. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.