NCT07487519
Not yet recruiting
Phase 2
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).
Shanghai Henlius Biotech1 site in 1 country180 target enrollmentStarted: April 25, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- ORR
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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).
Exclusion Criteria
- •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.
- •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 .
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60
Not yet recruiting
Not Applicable
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic CancerNCT07301229Shanghai Henlius Biotech100
Recruiting
Phase 1
Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid TumorsNCT07278479Molecular Partners AG138
Active, not recruiting
Phase 1
Phase I Clinical Study to Assess Safety and Efficacy of Repotrectinib Combined with Osimertinib in Patients with Advanced, Metastatic EGFR Mutant NSCLC (TOTEM).2023-509776-41-00Instituto Oncologico Dr. Rosell S.L.48
Recruiting
Phase 1
A Clinical Trial of P134 Cells in Recurrent GlioblastomaNCT07318818Tasly Pharmaceutical Group Co., Ltd26