Locally advanced unresectable or metastatic cancer
Conditions
Interventions
Cohort F: GB268 + Albumin Paclitaxel for Injection:GB268 + Albumin Paclitaxel for Injection
Cohort E: GB268 + Dedatuximab for Injection:GB268 + Dedatuximab for Injection
Cohort D: GB268 + Leralcil Hydrochloride + Letrozole:GB268 + Leralcil Hydrochloride + Letrozole
Cohort G: GB268:GB268
Cohort C: GB268 + Entinostat Tablets + Exemestane:GB268 + Entinostat Tablets + Exemestane
Cohort B: GB268 + Albumin-bound Paclitaxel for Injection:GB268 + Albumin-bound Paclitaxel for Injection
Cohort A: GB268 + Lucatumumab for Injection:GB268 + Lucatumumab for Injection
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Female or male aged >= 18 years at the time of signing the informed consent form; 2. Histologically confirmed locally advanced unresectable or metastatic breast cancer (TNBC or HR+/HER2- [HER2 negativity is defined as IHC 0, IHC 1+, or IHC 2+/ISH-]); subtype determination (ER/PR/HER2 status) shall be based on tumor tissue samples tested via IHC and/or ISH, and subject to the most recent biopsy results available for the advanced disease; 3. At least one measurable lesion as per RECIST 1.1 criteria (the measurable lesion shall not be located in the previous radiotherapy field unless definite progression is confirmed by imaging); 4. No prior treatment with any immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibodies) or bispecific antibodies targeting PD-1/VEGF (such as ivonescimab), except for those who relapse >=12 months after discontinuation of immunotherapy administered as adjuvant treatment; 5. As assessed by the investigator, the participant is eligible to receive the combination therapy regimen specified for the cohort they are enrolled in; 6. ECOG performance status of 0 or 1; 7. Life expectancy >= 3 months; 8. Major organ functions meet the following criteria (within 14 days prior to the first dose, without blood transfusion or G-CSF treatment): (1) alkaline phosphatase (ALP) = 50 mL/min (Cockcroft-Gault formula); (4) urine protein test strip = 2+, 24-hour urinary protein quantification < 1 g is required); (5) coagulation function INR or aPTT <= 1.5×ULN (for subjects not receiving anticoagulant therapy); 9. FFPE (formalin-fixed paraffin-embedded) tumor tissue samples available for biomarker testing shall be provided: fresh biopsy tissues from metastatic lesions (excluding bone metastases) or unresectable locally recurrent lesions are preferred; if fresh tissues are unavailable, archived FFPE tissues collected within 2 years prior to the first dose and not from previous radiotherapy areas may be provided. Tissue samples shall meet the basic quality requirements for subtype determination (IHC/ISH) and biomarker testing, as detailed in the study laboratory manual; 10. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, and agree to use effective contraceptive measures during the study period and for at least 6 months after the last dose; male patients must agree to practice contraception and refrain from donating sperm during the study period and for at least 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Prior to the initiation of the study treatment, the subject has received any of the following treatments or medications: (1) Systemic anti-tumor therapy, including chemotherapy, biological agents, etc., within 3 weeks prior to the first dose; hormonal anti-tumor therapy or small molecule targeted therapy within 2 weeks prior to the first dose; and herbal Chinese medicine or Chinese patent medicine products with anti-tumor indications taken within 2 weeks prior to the first dose. Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) received within 2 weeks prior to the first dose; (2) Vaccination with live or attenuated vaccines within 4 weeks prior to the first dose; (3) Radiotherapy within 3 weeks prior to the first dose. Palliative radiotherapy for symptom control is permitted if administered at least 2 weeks prior to the first dose. 2. Has received systemic immunosuppressive therapy (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to the first dose. The following are exceptions: (1) Participants who have received low-dose (=3 or irAEs (excluding grade 3 hypothyroidism that can be controlled via hormone replacement therapy). Participants who experienced grade >=3 toxicities associated with anti-angiogenic therapy or treatment discontinuation due to such toxicities (however, participants with grade 3 hypertension or grade 3 proteinuria may be enrolled only after a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;DLT incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADA;PK; | — |
Countries
China
Contacts
Public ContactBinghe Xu
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed