This study is a multicenter, non-randomized, open-label, Phase Ib/II combination therapy trial. The trial consists of two parts: Part 1 (Phase Ib), dose-escalation of combination therapy, followed by Part 2 (Phase II), tumor-type exploration of combination therapy. This study will evaluate the RP2D, safety, tolerability, and preliminary efficacy of BM230 in combination with PD-1 inhibitor in patients with HER2-related solid tumors (including but not limited to colorectal cancer, esophageal squamous cell carcinoma, urothelial carcinoma, cholangiocarcinoma, endometrial cancer, cervical cancer, ovarian cancer, etc.).
Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF)
Males and Females≥18 years old（at the time consent is obtained）
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1
Life expectancy of ≥ 3 months
Have received prior treatment with anti-HER2 antibody agents (excluding HER2 ADC agents).
Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive therapy for more than 28 days within the last 3 years, or clinically relevant immuno-deficiency diseases (eg, agammaglobulinemia or congenital
Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)
Anti-neoplastic treatments such as chemotherapy, biological therapy, endocrine therapy and immunotherapy within 3 weeks before the first dose
Sequential
BM230 & PD-1 inhibitor
DrugBM230: SC injection; PD-1 inhibitor: IV infusion
BM230 & PD-1 inhibitor
DrugBM230: SC injection; PD-1 inhibitor: IV infusion
DLT
Dose limiting toxicity
AEs
Adverse events
MTD and/or RP2D
The maximum tolerated dose (MTD) and/or the recommended phase 2 dose
ORR
Objective response rate assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
AUC
area under the concentration-time curve
Cmax
maximum concentration
Ctrough
trough concentration
CL
clearance rate
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
