NCT07294508 A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
| NCT ID | NCT07294508 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Henlius Biotech |
| Condition | HER2 + Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 706 participants |
| Start Date | 2026-02-27 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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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 706 participants in total. It began in 2026-02-27 with a primary completion date of 2028-01-15.
⚠ 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
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
Eligibility Criteria
Inclusion Criteria: * 1\. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria: 1. Advanced or metastatic breast cancer. 2. HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+. 3. Positive or negative for hormone receptor HR (including estrogen receptor \[ER\] and progesterone receptor \[PgR\]) as determined by the central laboratory 4. 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 v1.1. 7\. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1. 8\. Life expectancy ≥ 12 weeks. 9. Adequate organ functions Exclusion Criteria: * 1\. History of a second malignancy within 3 years prior to signing the ICF. 2. 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 5. 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 . 8. 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. 11. 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. 14. Pregnant or lactating women.
Contact & Investigator
Fei Ma, Dr
PRINCIPAL INVESTIGATOR
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Frequently Asked Questions
Who can join the NCT07294508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2 + 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 NCT07294508 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 NCT07294508 currently recruiting?
Yes, NCT07294508 is actively recruiting participants. Contact the research team at Maoqing_fu@henlius.com for enrollment information.
Where is the NCT07294508 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07294508 clinical trial?
NCT07294508 is sponsored by Shanghai Henlius Biotech. The principal investigator is Fei Ma, Dr at Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. The trial plans to enroll 706 participants.
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