Breast Cancer (Triple Negative Breast Cancer (TNBC))Phase 2NCT07487519
Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.
A Phase 2 study testing HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC and HLX43 DOSE 1 + HLX10 in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)), run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer (Triple Negative Breast Cancer (TNBC))
- What is being tested?
- HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC and HLX43 DOSE 1 + HLX10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2026to 22 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent obtained before any study procedures.
- Age ≥ 18 years at consent; no gender restriction.
- Histopathologically confirmed TNBC: ER < 1%, PR < 1%, HER2 IHC 0/1+/2+ with no FISH amplification.
- Phase I: Recurrent or metastatic TNBC after ≥1 prior line of standard systemic therapy.
- Phase II: Unresectable locally advanced, recurrent, or metastatic TNBC with no prior systemic anti-cancer therapy for this stage (palliative radiotherapy to metastases allowed; neoadjuvant/adjuvant therapy permitted if completed ≥6 months before recurrence/metastasis).
- At least one RECIST v1.1-measurable lesion documented within 4 weeks before randomization.
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- Note: Target lesions must not be in irradiated fields or the CNS. If only measurable lesion is irradiated, imaging must confirm progression post-radiotherapy.
- Archival FFPE tumor tissue (≤6 months old, ≤2 years max) for PD-L1 testing; fresh biopsy acceptable if archival tissue is unavailable or inadequate.
- Note: Specimens must be non-irradiated FFPE blocks/slides with pathology report confirming malignancy and adequacy.
- Washout: ≥3 weeks (or 5 half-lives, whichever is shorter) after major surgery, radiotherapy (except palliative bone RT), chemotherapy, targeted therapy, or immunotherapy; ≥1 week after minor surgery or anti-tumor TCM. All treatment-related AEs resolved to CTCAE v6.0 Grade ≤1 (stable Grade 2 peripheral neuropathy and alopecia exempted).
- ECOG PS 0-1, assessed ≤7 days before randomization.
- Life expectancy >3 months.
- Adequate hematologic, hepatic, and renal function per labs ≤7 days before randomization.
Who cannot join
- Prior topoisomerase I-targeting therapy (e.g., irinotecan, topotecan, or ADCs).
- Second primary malignancy within 2 years before randomization (except cured carcinoma in situ or stage I tumors).
- Prior grade ≥3 immune-related adverse event during immunotherapy.
- Uncontrolled, recurrent malignant pleural, pericardial, or ascitic effusions requiring repeated drainage.
- Active CNS metastases, spinal cord compression, or carcinomatous meningitis.
- Clinically significant pulmonary impairment.
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- Uncontrolled cardiovascular or cerebrovascular disease .
- Active systemic infection requiring IV antibiotics within 2 weeks before randomization.
- Moderate or strong CYP2D6/CYP3A inhibitor or inducer use within 2 weeks before randomization.
- Systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 2 weeks before randomization .
- Active or suspected autoimmune disease .
- Live or attenuated live vaccine within 4 weeks before randomization.
- Hypersensitivity to mAbs, large-molecule biologics, or drug formulation excipients.
- Active pulmonary tuberculosis.
- Known immunodeficiency.
- Active HBV , HCV , or HBV/HCV co-infection.
- Pregnancy or lactation.
- Participation in another interventional trial within 30 days before consent .
- Any condition posing unacceptable safety risk or interfering with study conduct per investigator judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150081
Tong Liu, Dr, 86-15945953777, Liutong@hrbmu.edu.cn
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) as a Monotherapy or in Combination With Immune Checkpoint Inhibitors in Subjects With Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (TNBC).
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).
- Being tested
- HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC, HLX43 DOSE 1 + HLX10, HLX43 DOSE1 IN 1L TNBC, HLX43 DOSE 2 IN 1L TNBC
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX43 DOSE 1 IN ≥2L TNBCDrug
Dose 1; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 DOSE 2 IN ≥2L TNBCDrug
Dose 2; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 DOSE 1 + HLX10Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.
HLX43 DOSE1 IN 1L TNBCDrug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 DOSE 2 IN 1L TNBCDrug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 DOSE2 + HLX10Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| armA: HLX43 DOSE 1 in ≥2L TNBC | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 DOSE 1 IN ≥2L TNBC |
| armB: HLX43 DOSE 2 in ≥2L TNBC | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 DOSE 2 IN ≥2L TNBC |
| armC: HLX43 DOSE 1 in 1L TNBC | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 DOSE1 IN 1L TNBC |
| armD: HLX43 DOSE 2 in 1L TNBC | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 DOSE 2 IN 1L TNBC |
| armE: HLX43 DOSE 1+ HLX10 in 1L TNBC | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 DOSE 1 + HLX10 |
| armF: HLX43 DOSE 2+ HLX10 in 1L TNBC | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 DOSE2 + HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) (assessed by BICR according to the RECIST v1.1 criteria)
Measured: up to 24 weeks
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by BICR according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start25 Apr 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion22 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Triple Negative Breast Cancer (TNBC))Studies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487519
- Sponsor's protocol ID
- HLX43-BC202
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) as a Monotherapy or in Combination With Immune Checkpoint Inhibitors in Subjects With Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (TNBC).
- ClinicalTrials.gov ID
- NCT07487519
- Acronym / sponsor ID
- HLX43-BC202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 22 May 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| armA: HLX43 DOSE 1 in ≥2L TNBC | Experimental | Drug: HLX43 DOSE 1 IN ≥2L TNBCPatients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| armB: HLX43 DOSE 2 in ≥2L TNBC | Experimental | Drug: HLX43 DOSE 2 IN ≥2L TNBCPatients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| armC: HLX43 DOSE 1 in 1L TNBC | Experimental | Drug: HLX43 DOSE1 IN 1L TNBCPatients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| armD: HLX43 DOSE 2 in 1L TNBC | Experimental | Drug: HLX43 DOSE 2 IN 1L TNBCPatients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| armE: HLX43 DOSE 1+ HLX10 in 1L TNBC | Experimental | Drug: HLX43 DOSE 1 + HLX10Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| armF: HLX43 DOSE 2+ HLX10 in 1L TNBC | Experimental | Drug: HLX43 DOSE2 + HLX10Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary written informed consent obtained before any study procedures.
- Age ≥ 18 years at consent; no gender restriction.
- Histopathologically confirmed TNBC: ER < 1%, PR < 1%, HER2 IHC 0/1+/2+ with no FISH amplification.
- At least one RECIST v1.1-measurable lesion documented within 4 weeks before randomization.
- Note: Target lesions must not be in irradiated fields or the CNS. If only measurable lesion is irradiated, imaging must confirm progression post-radiotherapy.
Key exclusion criteria (19 listed)
- Prior topoisomerase I-targeting therapy (e.g., irinotecan, topotecan, or ADCs).
- Second primary malignancy within 2 years before randomization (except cured carcinoma in situ or stage I tumors).
- Prior grade ≥3 immune-related adverse event during immunotherapy.
- Uncontrolled, recurrent malignant pleural, pericardial, or ascitic effusions requiring repeated drainage.
- Active CNS metastases, spinal cord compression, or carcinomatous meningitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX43 DOSE 1 IN ≥2L TNBCDose 1; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | armA: HLX43 DOSE 1 in ≥2L TNBC |
| HLX43 DOSE 2 IN ≥2L TNBCDose 2; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | armB: HLX43 DOSE 2 in ≥2L TNBC |
| HLX43 DOSE 1 + HLX10HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. | Drug | armE: HLX43 DOSE 1+ HLX10 in 1L TNBC |
| HLX43 DOSE1 IN 1L TNBCHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | armC: HLX43 DOSE 1 in 1L TNBC |
| HLX43 DOSE 2 IN 1L TNBCHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | armD: HLX43 DOSE 2 in 1L TNBC |
| HLX43 DOSE2 + HLX10HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. | Drug | armF: HLX43 DOSE 2+ HLX10 in 1L TNBC |
Primary outcome
ORR
Time frame: up to 24 weeks
Objective response rate (ORR) (assessed by BICR according to the RECIST v1.1 criteria)
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by BICR according to the RECIST v1.1 criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC and HLX43 DOSE 1 + HLX10 in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)), run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangyun Wang (86-13391626886, Xixangyun_Wang@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.