GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEddingpharm (Zhuhai) Co., Ltd.
About this trial
This is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.
Eligibility criteria
Qualifiers
Age ≥ 18 years, male or female.
Histologically confirmed locally advanced unresectable or metastatic breast cancer (Triple-Negative Breast Cancer [TNBC] or Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative [HR+/HER2-]).
At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1].
No prior treatment with any immune checkpoint inhibitor (e.g., anti-Programmed Death-1 [PD-1], anti-Programmed Death-Ligand 1 [PD-L1], anti-Cytotoxic T-Lymphocyte-Associated Protein 4 [CTLA-4]) or Programmed Death-1/Vascular Endothelial Growth Factor [PD-1/VEGF] bispecific antibody, except for adjuvant therapy if relapse occurred ≥12 months after discontinuation.
Disqualifiers
Prior anti-cancer therapy within specified washout periods.
Systemic immunosuppressive therapy within 2 weeks before first dose.
Major surgery or significant traumatic injury within 4 weeks before first dose.
Unresolved toxicity from prior therapy > Grade 1 (except alopecia or Grade ≤2 hypothyroidism stable on hormone replacement).
Trial design
Treatments tested in this trial
- GB268
- Nab-Paclitaxel
- Datopotamab Deruxtecan (Dato-DXd)
- Sacituzumab Tirumotecan
Treatment groups
270 Participants
are divided into 5 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov