Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients Wit… (NCT07487519) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.
China180 participantsStarted 2026-04-25
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.
✓. At least one RECIST v1.1-measurable lesion documented within 4 weeks before randomization.
✓. Archival FFPE tumor tissue (≤6 months old, ≤2 years max) for PD-L1 testing; fresh biopsy acceptable if archival tissue is unavailable or inadequate.
✓. 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.
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.
What they're measuring
1
ORR
Timeframe: up to 24 weeks
2
PFS
Timeframe: 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